A perfect key to success by these PANCE real questions

If you really to show your professionalism so just Passing the PANCE exam is not sufficient. You should have enough Physician Assistant National Certifying knowledge that will help you work in real world scenarios. Killexams.com specially focus to improve your knowledge about PANCE objectives so that you not only pass the exam, but really get ready to work in practical environment as a professional.

Exam Code: PANCE Practice test 2022 by Killexams.com team
PANCE Physician Assistant National Certifying

The material on NCCPA's certification and recertification exams can be organized in two dimensions: Organ systems and the diseases, disorders and medical assessments physician assistants encounter within those systems; and The knowledge and skills physician assistants should exhibit when confronted with those diseases, disorders and assessments.

Please note that while the subject matter covered on the certification and recertification exams is the same, there is some difference in the nature of the questions on those exams. Generally, the questions on the initial certification test are more specific, while questions on the recertification test tend to address broader clinical issues. This difference is most apparent in the questions related to applying basic science concepts and reflects the different functions of the two exams.

Note: Because of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) publication, NCCPA will adapt its content blueprints, disease and disorder lists, and psychiatry-related terminology within test questions to conform to DSM-5 classifications and diagnostic criteria for all of our examinations.
In NCCPA examinations, psychiatry-related terminology within test questions will include the DSM-5 terminology followed by the DSM-IV-TR terminology in parentheses. Example: illness anxiety disorder (hypochondriasis)

Based on delays in implementation of DSM-5 guidelines within the field of psychiatry, NCCPA will continue to present psychiatry-related terminology within test questions in the manner outlined above until further notice.

Beginning in 2019, there was a new content blueprint released for the Physician Assistant National Certifying Examination (PANCE). The content blueprint provides guidance on the information assessed on the Physician Assistant National Certifying Examination (PANCE). The examination is categorized in two dimensions:
Knowledge of the diseases and disorders physician assistants encounter; and Knowledge and skills related to tasks physician assistants perform when treating patients.
The detailed listings provided under each of these two categories represent examples of the material that may be covered on PANCE. It is not possible to include all courses on a single exam, and it may be possible that some questions on the test cover content that is not listed in the examples.

The content blueprint for PANCE is based on information provided from certified physician assistants who participate in profession-wide practice analysis studies. Certified PAs are involved throughout the test development process, including: reviewing results of the practice analysis, writing questions that appear on PANCE, reviewing exams before they are administered, reviewing performance data for test questions, and developing recommendations for the passing standard. Certified PAs work with NCCPA to continuously review the content included on PANCE to ensure it is relevant and current, as the practice of medicine changes and treatment guidelines are revised or new ones introduced.

Cardiovascular System 13%
Dermatologic System 5%
Endocrine System 7%
Eyes, Ears, Nose, and Throat 7%
Gastrointestinal System/Nutrition 9%
Genitourinary System (Male and Female) 5%
Hematologic System 5%
Infectious Diseases 6%
Musculoskeletal System 8%
Neurologic System 7%
Psychiatry/Behavioral Science 6%
Pulmonary System 10%
Renal System 5%
Reproductive System (Male and Female) 7%
History Taking and Performing Physical Examination 17%
Using Diagnostic and Laboratory Studies 12%
Formulating Most Likely Diagnosis 18%
Managing Patients
Health Maintenance, Patient Education, and Preventive Measures 10%
Clinical Intervention 14%
Pharmaceutical Therapeutics 14%
Applying Basic Scientific Concepts 10%
Professional Practice 5%

Physician Assistant National Certifying
Medical Certifying Questions and Answers
Killexams : Medical Certifying mock test - BingNews https://killexams.com/pass4sure/exam-detail/PANCE Search results Killexams : Medical Certifying mock test - BingNews https://killexams.com/pass4sure/exam-detail/PANCE https://killexams.com/exam_list/Medical Killexams : Should You Pursue Certification in Lifestyle Medicine? Yes

Physician colleagues often ask me what the future holds for lifestyle medicine and whether they should pursue board certification. My short answer to the second question is "Yes, absolutely!" But first I share why I am confident that lifestyle medicine will become a foundation of all health and healthcare and that clinicians should prepare for it.

Cate Collings, MD

There is increasing recognition among policymakers and health leaders of the unsustainable costs — in human suffering and the $4.1 trillion spent on US healthcare in 2020 — of lifestyle- and diet-related chronic diseases such as type 2 diabetes, obesity, and heart disease. COVID-19 and the worse outcomes associated with underlying chronic conditions contributed to awareness of just how sick Americans have become. The pandemic also shone a light on health disparities related to underlying lifestyle-related chronic disease prevalence and insufficient healthcare resources in many communities. Lifestyle medicine offers a promising path to narrow the health disparities gap.

Notably, for the first time in 50 years, the White House hosted a Conference on Hunger, Nutrition, and Health in September, with the goal to "[e]nd hunger and increase healthy eating and physical activity by 2030, so that fewer Americans experience diet-related diseases."

This growing recognition that we must reduce lifestyle-related diseases and prepare future and practicing clinicians to address the root causes of those diseases will ideally accelerate the US transition to high-value care. Lifestyle medicine leverages behavior changes in nutrition, physical activity, sleep, stress management, social connections, and use of risky substances as the first and primary way to treat many conditions, with medications and procedures as adjunctive treatment. It supports the Quintuple Aim of improved outcomes, lower costs, improved patient satisfaction, and improved provider satisfaction and has the potential to address health equity.

There is a strong case that value is precisely what lifestyle medicine can deliver, and this paves the way for paradigm change.

Health systems are increasing recognizing this value. The Health Systems Council, a collaborative community of health systems interested in integrating lifestyle medicine founded by the American College of Lifestyle Medicine (ACLM) in May 2021, already has more than 70 health system members. Accountable care organizations with a focus on lifestyle medicine have been created to help providers sustainably implement lifestyle behavior interventions. Even the US military is incorporating lifestyle medicine into its medical care for service members.

Momentum is growing for embedding lifestyle medicine into undergraduate medical education and build a new physician workforce tailored to current and future times. In November 2021, Rep. James McGovern introduced House Resolution 784, a resolution that passed the House supporting activities to ensure that health professional training programs, including medical schools, residency programs, and fellowships, incorporate substantive training in nutrition and diet.

The University of South Carolina School of Medicine Greenville is the first school to integrate lifestyle medicine into all 4 years of its curriculum. The Lifestyle Medicine Education Collaborative, a collection of open-access lifestyle medicine curricular resources developed there, provides a curriculum that other medical programs can integrate. Medical students have a hearty appetite for lifestyle medicine, and lifestyle medicine interest groups (LMIGs) for medical and other health professions students have exploded from a single campus in 2009 to 95 LMIGs today.

As of September 1, ACLM's Lifestyle Medicine Residency Curriculum (LMRC), a comprehensive curriculum piloted in 2018 that prepares residents to make evidence-based, lifestyle behavior interventions, is being implemented in 200 residency programs across 96 sites, with 1190 faculty and 4185 residents.

Lifestyle medicine education for physicians who trained 10 or more years ago may have consisted only of a few hours of learning about abject nutrient deficiencies and general suggestions to inspire patients to "exercise more" and "eat better." That's why I strongly urge practicing clinicians to pursue certification in lifestyle medicine. Education and certification will modernize their practice to meet current healthcare system needs.

As health systems or practices embrace lifestyle medicine and work within value-based contracts or population health goals, clinicians prepared with lifestyle medicine tools and knowledge will be valued and sought. More and more physicians and other clinicians are pursing board certification. Since 2017, 2004 US physicians and 778 other health professionals have certified.

Physicians are certified by the American Board of Lifestyle Medicine (ABLM). There are two pathways for physicians to qualify to take the exam. One is the experiential pathway for physicians who are already board-certified by a medical specialty board recognized by the American Board of Medical Specialties or the American Osteopathic Association. Those physicians must be primary board-certified and have practiced medicine for at least 2 years before qualifying to take the ABLM exam.

 The other emerging pathway is educational. Physicians who complete the LMRC through a residency site are eligible to sit for the certification exam, though certification will not be issued until the physician successfully passes the primary board exam.

To prepare for the board exam, ACLM provides a catalogue of on-line courses for continuing medical education as well as a lifestyle medicine board review course. In addition, ACLM recently became a content provider to Ed Hub, the American Medical Association's online learning platform. And the annual ACLM conference is a learning and networking event in the journey towards board certification.

The healthcare landscape is shifting rapidly. Transformative changes are occurring, and I am confident that lifestyle medicine will be at the forefront to address our alarming trajectory of chronic disease and its associated misery and financial impact.

Follow Medscape on Facebook, Twitter, Instagram, and YouTube

Wed, 05 Oct 2022 08:29:00 -0500 en text/html https://www.medscape.com/viewarticle/981797
Killexams : What you need to know about medical debt and your credit scores

Dear Liz: I disputed a medical charge for around $350. A few months later I received a collections notice. I then called the medical provider, who said they would suspend the collections while the dispute was being reviewed. There was no further communication for over a year, then out of the blue I received a derogatory remark from the collections agency. I monitor my credit scores via my credit card accounts. Two cards are driven by TransUnion data. One reported a drop from 802 to 706 while the other reported a drop from 809 to 774. My other card provides a score driven by Equifax and that one remained unchanged at 822. I’m curious about the discrepancies in these scores, and also about the length of time it will take for my credit score to recover if I do not try to resolve the derogatory remark or disputed medical bill.

Answer: Credit scoring formulas vary considerably in how they treat medical debt. Some older scoring models treat unpaid medical bills the same as any other collection account. Newer formulas may treat medical debt less harshly, reflecting research that shows these bills aren’t as reliable an indicator of creditworthiness as other collection accounts. Some of the latest formulas ignore paid medical debt entirely.

Earlier this year, the Consumer Financial Protection Bureau questioned whether medical debt should be included on credit reports at all. Less than three weeks later, the three credit bureaus announced that nearly 70% of medical debts would be removed from credit reports by the middle of next year.

Paid medical collections have already been eliminated from people’s credit reports, and unpaid bills won’t be reported to the bureaus for 12 months (an increase from the current six months). By June 30, 2023, the bureaus also will stop reporting any medical debt under $500.

You can wait for that to happen next year, or you can pay the bill and have it removed from your credit reports more promptly.

Dear Liz: What are the implications for Social Security if you plan to work past age 70? If you start at 70, are your benefits reduced because you’re working? Do you get any benefit from delaying past 70?

Answer: Your benefit maxes out at age 70, and your earnings won’t reduce your checks, so there’s no reason to delay your application past that point.

You stop being subjected to the earnings test once you reach your full retirement age, which is currently between 66 and 67. If you apply before that point, the earnings test reduces your benefits by $1 for every $2 you earn over a certain amount ($19,560 in 2022). That money isn’t gone for good — the withheld benefits are gradually added back in to future checks once you’re past full retirement age.

The big incentive to delay your application past full retirement age is the delayed retirement credits that boost your benefit by 8% each year you postpone your application until age 70. And as mentioned in previous columns, benefits also earn cost-of-living increases whether you’ve started them or not. People who are opting to delay the start of their benefits won’t miss out on the 8.7% increase for 2023.

Dear Liz: I looked up my financial advisor’s name in the link you provided to verify someone as a Certified Financial Planner (cfp.net/verify-a-cfp-professional), and he wasn’t there. I went back to his bio and it says he is fee only and he is an AIF (Accredited Investment Fiduciary). Is that the same? Or approximately the same?

Answer: An AIF designation indicates that the advisor has been trained to act as a fiduciary, which is someone committed to putting their clients’ best interests first. Most advisors are held to a lower “suitability” standard that allows them to recommend investments that are more expensive or perform worse than available alternatives, simply because the recommended investments pay the advisor more.

However, an AIF is not equivalent to a Certified Financial Planner credential. All CFPs are held to a fiduciary standard, but they’ve also been trained to offer comprehensive financial planning. The coursework, testing and experience requirements are much more rigorous for a CFP.

A credential that is similar to the CFP is the Personal Financial Specialist, which is a designation earned by certified public accountants. A CPA-PFS has extensive training in comprehensive financial planning, in addition to their tax expertise.

Liz Weston, Certified Financial Planner, is a personal finance columnist for NerdWallet. Questions may be sent to her at 3940 Laurel Canyon, No. 238, Studio City, CA 91604, or by using the “Contact” form at asklizweston.com.

Sun, 16 Oct 2022 00:00:00 -0500 en-US text/html https://www.latimes.com/business/story/2022-10-16/what-you-need-to-know-about-medical-debt-and-credit-scores
Killexams : The Talk - Botox Cosmetic: Answering Your Questions Wed, 12 Oct 2022 09:00:00 -0500 en-US text/html https://www.msn.com/en-us/health/medicalworld/the-talk-botox-cosmetic-answering-your-questions/vi-AA12Tyoh Killexams : Medical Device Testing, Inspection, and Certification Market Outlook and Forecast 2022 To 2028 with Top Countries Data

The MarketWatch News Department was not involved in the creation of this content.

Sep 30, 2022 (The Expresswire) -- "Medical Device Testing, Inspection, and Certification Market" Insights 2022 By Types, Applications, Regions and Forecast to 2028. The global Medical Device Testing, Inspection, and Certification market size is projected to reach Multimillion USD by 2028, In comparison to 2021, with unexpected CAGR during the forecast period 2022-2028, the Medical Device Testing, Inspection, and Certification Market Report Contains Many pages Including Full TOC, Tables and Figures, and Chart with In-depth Analysis Pre and Post COVID-19 Market Outbreak Impact Analysis and Situation by Region.

The Global Medical Device Testing, Inspection, and Certification market is anticipated to rise at a considerable rate during the forecast period, between 2022 and 2028. In 2021, the market is growing at a steady rate and with the rising adoption of strategies by key players, the market is expected to rise over the projected horizon.

This report focuses on global and United States Medical Device Testing, Inspection, and Certification market, also covers the segmentation data of other regions in regional level and county level.

Due to the COVID-19 pandemic, the global Medical Device Testing, Inspection, and Certification market size is estimated to be worth USD million in 2022 and is forecast to a readjusted size of USD million by 2028 with a Impressive CAGR during the review period. Fully considering the economic change by this health crisis, by Type, Medical Device Testing, Inspection, and Certification accounting for % of the Medical Device Testing, Inspection, and Certification global market in 2021, is projected to value USD million by 2028, growing at a revised % CAGR in the post-COVID-19 period. While by Application, Medical Device Testing, Inspection, and Certification was the leading segment, accounting for over percent market share in 2021, and altered to an % CAGR throughout this forecast period.

The report on the "Medical Device Testing, Inspection, and Certification Market" covers the current status of the market including Medical Device Testing, Inspection, and Certification market size, growth rate, prominent players, and current competitive landscape. It also analyzes future opportunities and forecasts the market assessing the strategies of the key players in terms of merger and acquisitions, RandD investments, technological advancements. The report further provides key recent developments, profiling of key players, and market dynamics. The report further investigates and assesses the current landscape of the ever-evolving business sector and the present and future effects of COVID-19 on the Medical Device Testing, Inspection, and Certification market.

Global Medical Device Testing, Inspection, and Certification Scope and Market Size
Medical Device Testing, Inspection, and Certification market is segmented by region (country), players, by Type and by Application. Players, stakeholders, and other participants in the global Medical Device Testing, Inspection, and Certification market will be able to gain the upper hand as they use the report as a powerful resource. The segmental analysis focuses on revenue and forecast by region (country), by Type and by Application for the period 2017-2028.

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Report Scope and Segmentation:

Report Coverage

Details

Companies Mentioned

SGS Group, Element Materials Technology Group, Intertek, Dekra Certification, TUV SUD, UL LLC, TUV Rheinland, Merieux NutriSciences, F2 Labs, Eurofins Scientific, Freyr Solutions, Smithers

By Type

In-house, Outsourced

By Applications

Active Medical Devices, Non-Active Medical Devices

Value Projection

Multimillion USD by 2028

Growth Rate

Impressive CAGR from 2022 to 2028

Forecast Period

2022 to 2028

Price (SUL)

3350 USD

Base Year

2021

Segments Covered

By Type, By Application, By Geography

Get a sample Copy of the Medical Device Testing, Inspection, and Certification Report 2022

Medical Device Testing, Inspection, and Certification Market is further classified on the basis of region as follows:

● North America (United States, Canada and Mexico) ● Europe (Germany, UK, France, Italy, Russia and Turkey etc.) ● Asia-Pacific (China, Japan, Korea, India, Australia, Indonesia, Thailand, Philippines, Malaysia and Vietnam) ● South America (Brazil, Argentina, Columbia etc.) ● Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa)

This Medical Device Testing, Inspection, and Certification Market Research/Analysis Report Contains Answers to your following Questions

● What are the global trends in the Medical Device Testing, Inspection, and Certification market? Would the market witness an increase or decline in the demand in the coming years? ● What is the estimated demand for different types of products in Medical Device Testing, Inspection, and Certification? What are the upcoming industry applications and trends for Medical Device Testing, Inspection, and Certification market? ● What Are Projections of Global Medical Device Testing, Inspection, and Certification Industry Considering Capacity, Production and Production Value? What Will Be the Estimation of Cost and Profit? What Will Be Market Share, Supply and Consumption? What about Import and Export? ● Where will the strategic developments take the industry in the mid to long-term? ● What are the factors contributing to the final price of Medical Device Testing, Inspection, and Certification? What are the raw materials used for Medical Device Testing, Inspection, and Certification manufacturing? ● How big is the opportunity for the Medical Device Testing, Inspection, and Certification market? How will the increasing adoption of Medical Device Testing, Inspection, and Certification for mining impact the growth rate of the overall market? ● How much is the global Medical Device Testing, Inspection, and Certification market worth? What was the value of the market In 2020? ● Who are the major players operating in the Medical Device Testing, Inspection, and Certification market? Which companies are the front runners? ● Which are the recent industry trends that can be implemented to generate additional revenue streams? ● What Should Be Entry Strategies, Countermeasures to Economic Impact, and Marketing Channels for Medical Device Testing, Inspection, and Certification Industry?

Customization of the Report

Our research analysts will help you to get customized details for your report, which can be modified in terms of a specific region, application or any statistical details. In addition, we are always willing to comply with the study, which triangulated with your own data to make the market research more comprehensive in your perspective.

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Detailed TOC of Global Medical Device Testing, Inspection, and Certification Market Insights and Forecast to 2028

1 Study Coverage
1.1 Medical Device Testing, Inspection, and Certification Product Introduction
1.2 Market by Type
1.2.1 Global Medical Device Testing, Inspection, and Certification Market Size by Type, 2017 VS 2022 VS 2028
1.3 Market by Application
1.3.1 Global Medical Device Testing, Inspection, and Certification Market Size by Application, 2017 VS 2022 VS 2028

1.4 Study Objectives
1.5 Years Considered

2 Global Medical Device Testing, Inspection, and Certification Production
2.1 Global Medical Device Testing, Inspection, and Certification Production Capacity (2017-2028)
2.2 Global Medical Device Testing, Inspection, and Certification Production by Region: 2017 VS 2022 VS 2028
2.3 Global Medical Device Testing, Inspection, and Certification Production by Region
2.3.1 Global Medical Device Testing, Inspection, and Certification Historic Production by Region (2017-2022)
2.3.2 Global Medical Device Testing, Inspection, and Certification Forecasted Production by Region (2023-2028)
2.4 North America
2.5 Europe
2.6 China
2.7 Japan

3 Global Medical Device Testing, Inspection, and Certification Sales in Volume andamp Value Estimates and Forecasts
3.1 Global Medical Device Testing, Inspection, and Certification Sales Estimates and Forecasts 2017-2028
3.2 Global Medical Device Testing, Inspection, and Certification Revenue Estimates and Forecasts 2017-2028
3.3 Global Medical Device Testing, Inspection, and Certification Revenue by Region: 2017 VS 2022 VS 2028
3.4 Global Medical Device Testing, Inspection, and Certification Sales by Region
3.4.1 Global Medical Device Testing, Inspection, and Certification Sales by Region (2017-2022)
3.4.2 Global Sales Medical Device Testing, Inspection, and Certification by Region (2023-2028)
3.5 Global Medical Device Testing, Inspection, and Certification Revenue by Region
3.5.1 Global Medical Device Testing, Inspection, and Certification Revenue by Region (2017-2022)
3.5.2 Global Medical Device Testing, Inspection, and Certification Revenue by Region (2023-2028)
3.6 North America
3.7 Europe
3.8 Asia-Pacific
3.9 Latin America
3.10 Middle East andamp Africa

4 Competition by Manufactures
4.1 Global Medical Device Testing, Inspection, and Certification Production Capacity by Manufacturers
4.2 Global Medical Device Testing, Inspection, and Certification Sales by Manufacturers
4.2.1 Global Medical Device Testing, Inspection, and Certification Sales by Manufacturers (2017-2022)
4.2.2 Global Medical Device Testing, Inspection, and Certification Sales Market Share by Manufacturers (2017-2022)
4.2.3 Global Top 10 and Top 5 Largest Manufacturers of Medical Device Testing, Inspection, and Certification in 2022
4.3 Global Medical Device Testing, Inspection, and Certification Revenue by Manufacturers
4.3.1 Global Medical Device Testing, Inspection, and Certification Revenue by Manufacturers (2017-2022)
4.3.2 Global Medical Device Testing, Inspection, and Certification Revenue Market Share by Manufacturers (2017-2022)
4.3.3 Global Top 10 and Top 5 Companies by Medical Device Testing, Inspection, and Certification Revenue in 2022
4.4 Global Medical Device Testing, Inspection, and Certification Sales Price by Manufacturers
4.5 Analysis of Competitive Landscape
4.5.1 Manufacturers Market Concentration Ratio (CR5 and HHI)
4.5.2 Global Medical Device Testing, Inspection, and Certification Market Share by Company Type (Tier 1, Tier 2, and Tier 3)
4.5.3 Global Medical Device Testing, Inspection, and Certification Manufacturers Geographical Distribution
4.6 Mergers andamp Acquisitions, Expansion Plans

Get a sample Copy of the Medical Device Testing, Inspection, and Certification Market Report 2022

5 Market Size by Type
5.1 Global Medical Device Testing, Inspection, and Certification Sales by Type
5.1.1 Global Medical Device Testing, Inspection, and Certification Historical Sales by Type (2017-2022)
5.1.2 Global Medical Device Testing, Inspection, and Certification Forecasted Sales by Type (2023-2028)
5.1.3 Global Medical Device Testing, Inspection, and Certification Sales Market Share by Type (2017-2028)
5.2 Global Medical Device Testing, Inspection, and Certification Revenue by Type
5.2.1 Global Medical Device Testing, Inspection, and Certification Historical Revenue by Type (2017-2022)
5.2.2 Global Medical Device Testing, Inspection, and Certification Forecasted Revenue by Type (2023-2028)
5.2.3 Global Medical Device Testing, Inspection, and Certification Revenue Market Share by Type (2017-2028)
5.3 Global Medical Device Testing, Inspection, and Certification Price by Type
5.3.1 Global Medical Device Testing, Inspection, and Certification Price by Type (2017-2022)
5.3.2 Global Medical Device Testing, Inspection, and Certification Price Forecast by Type (2023-2028)

6 Market Size by Application
6.1 Global Medical Device Testing, Inspection, and Certification Sales by Application
6.1.1 Global Medical Device Testing, Inspection, and Certification Historical Sales by Application (2017-2022)
6.1.2 Global Medical Device Testing, Inspection, and Certification Forecasted Sales by Application (2023-2028)
6.1.3 Global Medical Device Testing, Inspection, and Certification Sales Market Share by Application (2017-2028)
6.2 Global Medical Device Testing, Inspection, and Certification Revenue by Application
6.2.1 Global Medical Device Testing, Inspection, and Certification Historical Revenue by Application (2017-2022)
6.2.2 Global Medical Device Testing, Inspection, and Certification Forecasted Revenue by Application (2023-2028)
6.2.3 Global Medical Device Testing, Inspection, and Certification Revenue Market Share by Application (2017-2028)
6.3 Global Medical Device Testing, Inspection, and Certification Price by Application
6.3.1 Global Medical Device Testing, Inspection, and Certification Price by Application (2017-2022)
6.3.2 Global Medical Device Testing, Inspection, and Certification Price Forecast by Application (2023-2028)

7 Medical Device Testing, Inspection, and Certification Consumption by Regions
7.1 Global Medical Device Testing, Inspection, and Certification Consumption by Regions
7.1.1 Global Medical Device Testing, Inspection, and Certification Consumption by Regions
7.1.2 Global Medical Device Testing, Inspection, and Certification Consumption Market Share by Regions

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8.1 North America
8.1.1 North America Medical Device Testing, Inspection, and Certification Consumption by Application
8.1.2 North America Medical Device Testing, Inspection, and Certification Consumption by Countries

9.2 United States
9.2.1 Canada
9.2.2 Mexico

10.1 Europe
10.1.1 Europe Medical Device Testing, Inspection, and Certification Consumption by Application
10.1.2 Europe Medical Device Testing, Inspection, and Certification Consumption by Countries
10.1.3 Germany
10.1.4 France
10.1.5 UK
10.1.6 Italy
10.1.7 Russia

11.1 Asia Pacific
11.1.1 Asia Pacific Medical Device Testing, Inspection, and Certification Consumption by Application
11.1.2 Asia Pacific Medical Device Testing, Inspection, and Certification Consumption by Countries
11.1.3 China
11.1.4 Japan
11.1.5 South Korea
11.1.6 India
11.1.7 Australia
11.1.8 Indonesia
11.1.9 Thailand
11.1.10 Malaysia
11.1.11 Philippines
11.1.12 Vietnam

12.1 Central and South America
12.1.1 Central and South America Medical Device Testing, Inspection, and Certification Consumption by Application
12.1.2 Central and South America Medical Device Testing, Inspection, and Certification Consumption by Countries
12.1.3 Brazil

13.1 Middle East and Africa
13.1.1 Middle East and Africa Medical Device Testing, Inspection, and Certification Consumption by Application
13.1.2 Middle East and Africa Medical Device Testing, Inspection, and Certification Consumption by Countries
13.1.3 Turkey
13.1.4 GCC Countries
13.1.7 Egypt
13.1.6 South Africa

14 Corporate Profiles

14.1.1 Corporation Information
14.1.2 Overview
14.1.3 Medical Device Testing, Inspection, and Certification Sales, Price, Revenue and Gross Margin (2017-2022)
14.1.4 Medical Device Testing, Inspection, and Certification Product Model Numbers, Pictures, Descriptions and Specifications
14.1.7 recent Developments

15 Industry Chain and Sales Channels Analysis
15.1 Medical Device Testing, Inspection, and Certification Industry Chain Analysis
15.2 Medical Device Testing, Inspection, and Certification Key Raw Materials
15.2.1 Key Raw Materials
15.2.2 Raw Materials Key Suppliers
15.3 Medical Device Testing, Inspection, and Certification Production Mode andamp Process
15.4 Medical Device Testing, Inspection, and Certification Sales and Marketing
15.4.1 Medical Device Testing, Inspection, and Certification Sales Channels
15.4.2 Medical Device Testing, Inspection, and Certification Distributors
15.7 Medical Device Testing, Inspection, and Certification Customers

16 Market Drivers, Opportunities, Challenges and Risks Factors Analysis
16.1 Medical Device Testing, Inspection, and Certification Industry Trends
16.2 Medical Device Testing, Inspection, and Certification Market Drivers
16.3 Medical Device Testing, Inspection, and Certification Market Challenges
16.4 Medical Device Testing, Inspection, and Certification Market Restraints

17 Key Finding in The Global Medical Device Testing, Inspection, and Certification Study

18 Appendix
18.1 Research Methodology
18.1.1 Methodology/Research Approach
18.1.2 Data Source
18.2 Author Details
18.3 Disclaimer

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Thu, 29 Sep 2022 23:24:00 -0500 en-US text/html https://www.marketwatch.com/press-release/medical-device-testing-inspection-and-certification-market-outlook-and-forecast-2022-to-2028-with-top-countries-data-2022-09-30 Killexams : Understanding Japan’s Medical Device Certification System

REGULATORY OUTLOOK

McRoberts

Japan's consumption of medical devices makes it an attractive market for global medical device manufacturers. But manufacturers hoping to sell their devices in Japan must pay careful attention to the revised Pharmaceutical Affairs Law (PAL). It aligns Japan's regulatory requirements more closely with those of other advanced nations. In this article, we examine the changes, challenges, and benefits of the revised PAL.

Ohyama

After the financial slowdown in the mid-1990s, Japan's economic fortunes have begun to increase—and so has the country's appetite for medical devices. In 2004, medical devices constituted an estimated $19 billion–market in Japan, larger than all other Asian markets. During the next few years, as Japan's economy continues to grow, imports of foreign medical devices are expected to grow by 5–8% annually and continue to represent 10% of the world market for medical devices.1

Kambeitz

Despite the favorable prospects for exporting medical devices to Japan, all foreign medical manufacturers must still contend with a legal requirement stipulating that all medical products be registered with the Japanese Ministry of Health, Labour, and Welfare (MHLW), Japan's equivalent of FDA. This law has become increasingly instrumental to Japan's device market because products grandfathered in prior to 2005 must comply with the revised PAL when their existing Shonin (regulatory approval) expires. Manufacturers will also have to deal with the PAL when they need to make a significant change to a product that would require premarket clearance. In Japan, medical device manufacturers and importers are also expected to demonstrate certain behaviors associated with corporate social responsibility. Hence, the Japanese government requires foreign device manufacturers to maintain a physical presence in Japan so that remedies for identified safety problems with a device can be applied immediately.

Amended Legislation for Medical Devices

The PAL is the most important legislation for foreign device firms hoping to sell products in the Japanese market. In July 2002, the Japanese House of Representatives passed the amended PAL, which is applicable to all medical devices, drugs, quasidrugs, and cosmetics entering the Japanese market. It became effective April 1, 2005, and has the following objectives:

  • To enhance safety measures for medical devices sold in Japan.
  • To strengthen postmarketing safety measures for medical devices.
  • To align Japan's medical device regulatory system with prevailing international systems.

In order to apply for the necessary regulatory clearance to market a device, manufacturers outside of Japan must appoint a marketing authorization holder (MAH) as their representative in Japan. The MAH may be a subsidiary of the manufacturer through common ownership or may be an independent entity, but the manufacturer must establish a detailed contract with the MAH in accordance with the requirements of the amended PAL and related ministerial ordinance (MO).

If a manufacturer wishes to have its subsidiary or sales office as the MAH, then the subsidiary must be licensed as an MAH by the appropriate prefecture (comparable to county) government in Japan in accordance with MOs 135 and 136. This enables the MAH to be accredited by MHLW to apply for PAL certification. Only these legal license holders can apply for and hold PAL certification of medical devices. For a foreign manufacturer to become an MAH on its own, it must be accredited as a special MAH by the Pharmaceuticals and Medical Devices Agency (PMDA), an executive arm of MHLW also known as Kiko. The manufacturer must also nominate a representative in Japan.

Under the amended PAL, foreign manufacturers of all classes of medical devices are also required to obtain foreign manufacturing accreditation for their manufacturing facilities. This accreditation can only be obtained by applying through the MAH to PMDA. MO 2 outlines the requirements for accreditation. Manufacturers that sold products in Japan before the PAL was amended may have been granted temporary foreign manufacturing accreditation, which means they can delay their application for accreditation until 2008. After 2008, foreign manufacturing facilities must be reaccredited under the new regulation (MO 2).

The Quality Management Systems Ministerial Ordinance on Medical Devices and In Vitro Diagnostics (MO 169, also known as the QMS ordinance), implemented in 2005, lacked certain requirements integral to ISO 13485:2003. These requirements, which outlined management responsibility, risk management in production, design controls (if applicable), criteria for suppliers, process validation, and analysis of data, were not mandatory in Japanese regulations until April 2007. Therefore, it is possible that early accreditation assessments to MO 169 did not include these elements. Manufacturers with a current Japanese QMS and those submitting new applications should ensure that these requirements are properly satisfied in time for surveillance visits.

Another key change brought by the revised PAL is that Class II medical devices, which are designated as controlled medical devices, have now shifted from ministerial-level approval to designated third-party approval (see Table I). In other words, MAHs for Class II medical devices can obtain a certification of product conformance from a registered third-party certification body rather than directly from PMDA. This change allows manufacturers to get their products certified faster and also tap into the technical expertise of third-party certification bodies. However, only certain designated Class II medical devices can benefit from the third-party approval process. A Japanese Industrial Standard (JIS)—a mandatory performance standard—must be established for a medical device to be eligible. In many instances, the mandatory JIS standard is equivalent to an IEC standard, such as the second edition of IEC 60601-1. Class II devices for which no JIS standard has been established may not use a third-party certification body and must apply to PMDA directly.

Out of the 4044 total device types identified by MHLW, only 1785 are designated as Class II, and less than half of those are currently designated as controlled medical devices eligible for third-party approval. The JIS conformity assessment standard and essential requirements are designated by MHLW by device type, which enables third-party assessment of such Class II devices. Article 41 of the revised PAL requires the minister to establish necessary standards after seeking the opinion of the Pharmaceutical Affairs Food and Sanitation Council (also called Bukai). The list of devices eligible for third-party approval is continually growing as MHLW approves additional essential-principles checklists.

An application for a Class II device license requires an assessment of the quality management system of the device manufacturer (including foreign manufacturers) to the requirements of MO 169. This ordinance is based entirely on ISO 13485:2003, with some additional requirements for the Japanese market. Manufacturers of Class II active medical devices may include or exclude requirements for design and development depending on the designation by MHLW. This assessment may be carried out by local assessors trained on Japanese requirements and qualified by the third party. Some third parties, because of the location of their audit staff, must dispatch their assessors from Japan and coordinate logistics, including travel and lodging for the audit team and its translators.

Obtaining a device license also involves an evaluation of the technical documentation for the medical device. This is similar to the requirements outlined in the Global Harmonization Task Force's Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices document. Japanese regulations may also require additional information, such as proof of compliance with the JIS performance standard. The MAH is required to present this information in Japanese to the third-party assessor.

Selecting a Third-Party Approval Body

There are a variety of services provided by third parties. By carefully choosing a third-party approval body, an MAH can take advantage of additional accreditations and services that the third-party organizations offer. Some third parties allow the supporting documents, which demonstrate a device's conformity to the applicable JIS or IEC standards, to be assessed in English (to supply a degree of confidence) before undergoing a costly translation process. Foreign manufacturers may want to consider this service when their original technical file has already been approved by another public health authority. Allowing supporting documents to be assessed in English would ensure that all requirements of the Japanese regulations are included in a device's technical file, since some requirements may be specific to the Japanese regulatory system.

A medical device company should also consider testing requirements when choosing its third party. Not all JIS standards are based on IEC requirements. If a device has already been tested for markets outside of Japan, it is possible that some of the mechanical and engineering decisions can be made based on previous tests, especially if the device is not electrical (nonactive) or if a switching power supply is used. (It is important to note that the electrical system in Japan is 100 V ac at both 50 and 60 Hz.)

Manufacturers that want to market devices in Japan should consider that marketing goal in their design phase and incorporate flexibility into their design to meet the country's requirements. This gives them a better opportunity to have EN (European Union), NRTL (United States and Canada), and JIS testing done simultaneously. Although additional samples and time may be needed to complete the JIS testing, a third party that is accredited in all of the company's current and anticipated sales markets can minimize redundant tests whenever possible.

As mentioned, the revised PAL brought with it a requirement to manufacture under an audited quality management system, which ensures conformity with JGMP requirements. When a device manufacturer chooses a third party, it should also consider the location of the JGMP-qualified auditors and whether the JGMP audit can be combined with the quality management system audits required by the United States, Canada, and the European Union.

FDA's accredited persons inspection program audits to 21 CFR 820 requirements, but the program is only open to those companies that are not under FDA scrutiny (i.e., increased FDA attention owing to nonconformities, product recalls, etc.). Because low-risk device manufacturers are only periodically audited by FDA and these audits cost very little, the only incentive for FDA establishments to use a third party for inspections is the predictability of the audit.

The European Union allows an ISO 13485–based audit to meet Annex V requirements under the Medical Devices Directive and Annex IV under the In Vitro Diagnostic Directive. The Canadian Medical Devices Conformity Assessment System is strictly based on ISO 13485. Therefore, many manufacturers maintain an ISO 13485 registration with many clauses and elements similar to JGMP requirements. As a result, third parties that offer accreditations for all of these regulatory programs can offer integrated audits, which are less time-consuming, less intrusive, and potentially less costly to the manufacturer.

Other considerations the MAH should make in choosing a third party are experience, trust, and the MAH's relationship with the organization. Bear in mind that all applications for device licensing to a third party can only be made through the MAH located in Japan to the third-party certification body in Japan. However, the value of local support for foreign manufacturers is worth considering in understanding the requirements these manufacturers must meet.

The Goal of Alignment

As indicated, one of the goals of the revised PAL was to align Japan's medical device regulatory system with those of other advanced nations, namely those of the United States and the European Union. Because these nations produce and consume the majority of the world's medical devices, the regulatory practices in these regions are generally the ones accepted and adopted by device manufacturers worldwide. Just as with the regulatory systems from these regions, Japan's revised PAL allows third parties to conduct assessments of Class II medical devices for certification to market and sell in a particular region. Both EU and U.S. health authorities also require an audit of each manufacturing location to ensure that the quality system conforms to GMPs. The last similarity is the identification of an in-country representative—the MAH in Japan, the agent in the United States, and the authorized representative (AR) in the European Union. The biggest difference is that the MAH, as the name implies, takes over ownership and responsibility for certification, whereas the AR and the agent work on behalf of the manufacturer.

Conclusion

Although the revised PAL aligns more closely with general international requirements for medical devices, demonstrating conformance with the PAL still requires manufacturers to invest time and effort to understand its requirements. Once the regulatory process is defined, manufacturers must still contend with the challenges and cost of device-specific processes for reimbursement, distribution, and packaging. However, if the Japanese medical device market continues to grow and maintains its need for foreign medical devices, meeting PAL and MHLW requirements may be a worthwhile investment for device manufacturers.

Steve McRoberts is Underwriters Laboratories' (UL) global principal engineer for medical regulatory programs. Seiko Ohyama is a lead engineering associate working for UL-Japan Inc. Tara Kambeitz is the global marketing manager for UL's medical business unit. She can be reached at [email protected].


1. U.S. International Trade Commission, Medical Devices and Equipment: Competitive Conditions Affecting U.S. Trade in Japan and Other Principal Foreign Markets, March 2007; available from Internet: http://hotdocs.usitc.gov/docs/pubs/332/pub3909.pdf.

Copyright ©2008 Medical Device & Diagnostic Industry

Wed, 12 Oct 2022 12:00:00 -0500 en text/html https://www.mddionline.com/news/understanding-japans-medical-device-certification-system
Killexams : New GHA Certification Helps Medical Tourism Facilitators Build Patient Trust

WEST PALM BEACH, Fla., Sept. 28, 2022 /PRNewswire/ -- Global Healthcare Accreditation (GHA) announces the launch of a new certification program for medical travel facilitators to assist in building patient trust. 

GHA Medical Travel Facilitator Certification

GHA's Medical Travel Facilitator Certification focuses on validating the capacity of medical tourism facilitator companies to provide appropriate services to clients that enhance safety and patient experience along the entire medical travel patient journey as appropriate to the facilitator company's business model.

Medical travel facilitators have for many years played an important role as intermediaries between patients and healthcare providers. Their services include providing information about the medical provider, handling travel logistics, and ensuring a smooth care journey.  For many patients, the medical travel facilitator is the main motivator or reason why they choose a specific destination provider. However, medical travel facilitation is an unregulated industry; therefore, it is not always easy for patients to distinguish between a facilitator with experience and high-quality partnerships versus another that has a beautiful website but little experience – or worse, is not focused on the patient's best interests.

According to Wiliam Cook, Global Healthcare Accreditation's Director of Business Development and Marketing, "The Medical Travel Facilitator Certification provides a trusted third-party validation that demonstrates to patients and healthcare providers that a facilitator's services meet the highest standards and align with international best practices. Patients no longer have to rely on anecdotes or unverified testimonials to make medical travel decisions, they can look to the Medical Travel Facilitator Certification as a metric to evaluate and validate a facilitator's capacity to provide the requisite services to ensure an excellent patient care journey."

The Medical Travel Facilitator Certification is conducted conveniently online, includes access to training, and evaluates a facilitator across 15 key competencies, including business ethics, sustainability and quality improvement, financial transparency, client services, oversight of contracts and agreements, and risk management, which underline a company's capacity to deliver excellent services.

For medical travel facilitator companies, the benefits of this certification include:

  • Enhance patient care experience along the entire care continuum
  • Provide a framework on which facilitators can implement or strengthen sound operational policies, procedures, and processes that align with global best practices
  • Offer a third-party validation that builds trust and confidence with prospective clients and health buyers
  • Increase brand awareness and visibility
  • Mitigate risks and vulnerabilities for clients and for the facilitator business

"Expect an increasing number of patients to look for accreditation or certification as the determinant in selecting a medical travel agent," said Bill Cook. "GHA's Medical Travel Facilitator Certification assures patients that a facilitator has been vetted by a globally recognized third-party accreditor, affirming that the company has the required protocols, processes, and staff training to deliver a safe and high-quality treatment journey and experience."

Visit https://www.globalhealthcareaccreditation.com/medical-travel-facilitator-certification to learn more about GHA's Medical Travel Facilitator Certification.

About Global Healthcare Accreditation

Founded in 2016, Global Healthcare Accreditation is the only accrediting body focused solely on medical travel and well-being services. GHA's international standards and professional norms for medical travel were developed in consultation with leading global experts in the industry, including providers, insurers, and employers committed to establish best practices in medical tourism, health tourism, and well-being, which support providers in validating quality and patient experience, increasing visibility, and implementing a sustainable business model for providers along the entire medical travel care continuum. GHA received ISQua's International Society for Quality in Health Care External Evaluation Association (IEEA) accreditation in 2019.

Organizations interested in contacting Global Healthcare Accreditation (GHA) can make a request at info@ghaccreditation.com | www.GlobalHealthcareAccreditation.com

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SOURCE Global Healthcare Accreditation

Tue, 27 Sep 2022 22:29:00 -0500 en text/html https://markets.businessinsider.com/news/stocks/new-gha-certification-helps-medical-tourism-facilitators-build-patient-trust-1031769401
Killexams : Comprehensive oncology clinic opens at Flagstaff Medical Center

Cancer Centers of Northern Arizona Healthcare (NAH) opened a new medical oncology clinic at the Flagstaff Medical Center (FMC) in July that offers comprehensive cancer services in one location for northern Arizona residents.

The clinic — called the NAH Medical Group–Medical Oncology Clinic -- offers a variety of cancer services for northern Arizona patients, including medical and radiation oncology and infusion. Its team has a number of specialists in different areas, including radiologists, pathologists, social workers and mastectomy fitters, as well as a nurse navigator, clinical pharmacist and genetic counselor.

The idea is to support patients through their treatment by responding to physical, emotional and social needs that might arise in their care.

“I want patients to be able to come here and have all the answers they need to be supported, to be able to call in and ask questions so that they can approach whatever treatment it is without fear," said Deborah Lindquist, MD, a board-certified medical oncologist and hematologist who leads the clinic.

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Oncology care in Flagstaff had been previously available in smaller practices throughout the city. While the dispersed options are still open for local patients, medical professionals who work at the new clinic say combining different cancer services in one location has benefits for both staff and patients.

“It definitely takes a multidisciplinary approach to be able to collectively care for all our oncology patients," said oncology service line administrator Amy Stapleton, BSN, RN, OCN. " ... By us opening up here, it allows us to have medical oncology, radiation oncology, as well as infusion services at one location -- which also allows our team members to collaborate in a bit more depth."

The clinic first opened July 11 after “a lot of behind-the-scenes work.”  A space in FMC’s west campus was remodeled and there was an effort made to communicate the changes to services offered.

It has two patient entryways: one for radiation oncology on the north side of the building, and one on the east side for medical oncology and outpatient infusion. These share a reception area to allow patients to easily access both areas of service as needed.

“It might start from somebody having an abnormal mammogram, for instance, and then they might need to come and see a medical oncologist and see what next needs to happen,” Lindquist said.

Lindquist added: “Often we work with all the surgeons and radiation doctors and medical oncology together. ... Sometimes it's helping with the diagnosis, sometimes they already have the diagnosis and we’re involved in how best to treat it. Then afterwards, it’s follow-up. Patients who have had cancer, they need to be followed regularly, need to know when they need CT scans or when they need mammograms. So we take care of that for them as well.”

The clinic also has plans for research getting started that focuses on breast cancer

“I think the importance of bringing the comprehensive program to Flagstaff is bringing all of their necessary care into, or closer to, [patients’] backyard,” Stapleton said. “We service patients all across northern Arizona, and being able to have one dedicated place for them to go takes a lot of that fear and that anxiety away for them.”

More about the clinic can be found at nahealth.com/cancer-centers-northern-arizona-healthcare, or by calling 928-773-2271.

Thu, 13 Oct 2022 01:30:00 -0500 Abigail Kessler en text/html https://azdailysun.com/news/local/comprehensive-oncology-clinic-opens-at-flagstaff-medical-center/article_e3b48766-48c9-11ed-b2bd-675bab337bfc.html
Killexams : EQS-News: Vitruvia Medical AG: Successful certification of FFP 2 masks with medical approval of LT technologies

EQS-News: VITRUVIA MEDICAL AG / Key word(s): Product Launch/Market Launch
Vitruvia Medical AG: Successful certification of FFP 2 masks with medical approval of LT technologies

30.09.2022 / 09:52 CET/CEST
The issuer is solely responsible for the content of this announcement.

Successful certification of FFP 2 masks with medical approval

of LT technologies

LT technologies has successfully passed the certification of the FFP2 masks with medical approval.

The TechMed Mask is a particle-filtering half mask for protection against aerosols, including viruses and particles. It is excellent for use in infection control and protects the wearer and those around them.

As LT technologies maintains a certified quality management system in accordance with the DIN EN ISO 13485:2016 standard, the respiratory protection mask was also certified in accordance with type IIR DIN/EN 14683:2016-10 in addition to TÜV Rheinland in accordance with DIN/EN 149:2001+A1:2009. This makes us one of the few manufacturers worldwide to produce masks with this double certification.

This FFP2 mask gives LT technologies a unique selling point. To date, there is no tm mask on the German market. The company is thus able to establish itself uniquely in Germany with its application in the medical sector and is optimally prepared for the next Corona wave. We assume that this aspect will become even more important. Supply bottlenecks from Asia have shown that European production is increasingly being used, if it is available.

LT technologies has already received the first orders. The FFP2 mask with medical approval will mainly be for hospital use, but the end user will probably also prefer this medical protection. From October 2022, we will produce the masks in-house "Made in Germany".

Further information about LT technologies GmbH &Co KG can be found on the home page : www.lt-technologies.de

About Vitruvia Medical AG :

Vitruvia Medical AG is a Swiss holding company with a focus on repair, production and trade of medical devices as well as surgical instruments.

Vitruvia thus combines innovative and sustainable solutions for medical-technical progress, customer benefit and economic success.

30.09.2022 CET/CEST Dissemination of a Corporate News, transmitted by EQS - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.eqs-news.com

Thu, 29 Sep 2022 20:00:00 -0500 en text/html https://markets.businessinsider.com/news/stocks/eqs-news-vitruvia-medical-ag-successful-certification-of-ffp-2-masks-with-medical-approval-of-lt-technologies-1031774879
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