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Quality/Regulatory

Featured Articles

June 15, 2022

Evidence Partners and Akra Team Join Forces To Help Medical Device Companies Accelerate Completion of EU MDR and IVDR Submissions

By MedTech Intelligence Staff

The partnership brings together Evidence Partners' literature review platform, DistillerSR, and Akra Team's strategic regulatory services.

June 15, 2022

FDA Issues Final Guidance on Technical Performance Assessments of Quantitative Imaging in Premarket Submissions

By MedTech Intelligence Staff

Manufacturers preparing premarket submissions should provide performance specifications for the quantitative imaging functions, supporting performance data, and sufficient information for the end user to obtain, understand and interpret the values provided.

June 15, 2022
Garrett Schumacher

The Shifting Sands of Medical Device Cybersecurity Regulation

By Garrett Schumacher

Old justifications or business reasons for security gaps are obsolesced. We need robust medical device cybersecurity, but we need it in a manner that is workable by both MDMs and HDOs.

June 8, 2022
Hand holding globe - diversity

AdvaMed Releases New Resource on Diversity in Clinical Research

By MedTech Intelligence Staff

“Approaches to Increasing Diversity in Clinical Research and Addressing Health Inequities” offers key recommendations for device manufacturers and developers on steps they can take to increase diversity in clinical research and address health equity.

June 8, 2022
Medical device recall

Medtronic Recalls HVAD Pump Implant Kit for Pump Weld Defect

An analysis of the HVAD pump implant kit showed moisture had entered the center post of the pump causing corrosion and demagnetization of the internal magnets, which may cause the pump to rotate incorrectly.

June 7, 2022
Sherry Parker, WuXi AppTec

Release Kinetics: An Important Element in Understanding Toxicological Risk of Chemical Constituents

By Sherry Parker, Ph.D.

The upcoming revision to ISO 10993-17 proposes the use of release kinetics data to support toxicological risk assessments. Manufacturers should expect that this data will be needed to help mitigate the risks identified in exhaustive extraction studies.

June 1, 2022
Bernstein_Mazur

Transforming Health Care: The Drive For Digital Health and Health IT

By Stephen Bernstein, Lisa Mazur

Rapid developments in healthcare technology, combined with improved data collection, pandemic pressures and increased consumer demand for tech-enabled and virtual health care, are fueling innovation and transformation in the digital health space.

May 31, 2022

FDA CDRH Announces Reopening for All IVD Pre-Submissions

By MedTech Intelligence Staff

As of June 1, 2022, the Center for Devices and Radiological Health plans to accept all non-COVID in vitro diagnostic (IVD) pre-submissions.

View More Quality/Regulatory Articles »

Columns

June 7, 2022

Optimizing Wearables

By Lisa Hedges
Lisa Hedges

Inaccurate data entry, discomfort and privacy concerns are among the issues that developers and designers must address to realize the promise of medical wearables.

April 25, 2022
Ameing for Asia

Is China Still A Good Opportunity For Device Manufacturers?

By Ames Gross
Ames Gross, Pacific Bridge Medical

The short answer is yes, but doing your homework in advance is now more important than ever.

April 22, 2022
Soapbox

Telemedicine Moved Forward During the Pandemic. Our Policies and Regulations Need to Catch Up

By Harry Glorikian
Harry Glorikian

Outdated policies and regulations threatens to bring progress to a standstill, restrict vital telehealth access to millions of Americans, and exacerbate health inequities.

March 28, 2022
Soapbox

Why the Future of U.S. Patient Care Begins with Interoperability

By Joerg Schwarz, Ph.D.
Joerg Schwarz, Infor

The combination of medtech progress with strides in modern healthcare interoperability will enable preventive care in unprecedented ways.

March 24, 2022
Soapbox

Three Things You Need to Know About FDA QSR and ISO 13485 Harmonization

By Etienne Nichols
Etienne Nichols, Greenlight Guru

New changes mean new challenges, but global harmonization could make things easier for device manufacturers in the long run.

Upcoming Events & Webinars

August 30, 2022 – 12:00 pm – 1:00 pm
Getting Your Regulatory Ducks in a Row – Why a Regulatory Information Strategy is Critical for Successful MDR/IVDR Transitions


On Demand Events & Webinars

June 16, 2022
Rethinking the Medical Device Supply Chain
June 15, 2022
End-to-end Data Integration, Health Records through Medical Devices (Connected Care: Digital Health, Wearables & Connectivity)
May 25, 2022
Supply Chain Quality Management
May 24, 2022
Literature Reviews Strategies for Post-Market Surveillance – A Best Practices Webinar
May 19, 2022 – 12:00 pm – 2:30 pm
User Experience & Patient Engagement (Connected Care: Digital Health, Wearables & Connectivity Series)
May 12, 2022 – 12:00 pm – 2:30 pm
Telemedicine and Healthcare Outside of the Hospital (Connected Care: Digital Health, Wearables & Connectivity)
March 30, 2022 – 12:00 pm – 1:00 pm
Checkmate: Post-Market Intelligence – A New Global Cost-Effective Strategy
March 16, 2022 – 12:00 pm – 2:30 pm
The Future is Now: Learning from Diabetes (Connected Care: Digital Health, Wearables & Connectivity Series)
January 20, 2022 – 1:00 pm – 2:00 pm
The Silver Lining in Labeling System Validation: Four Tangible Business Benefits
December 15, 2021 – 12:00 pm – 1:00 pm
Connectivity and Beyond – Transforming Medical Devices into Personalized Connected Care Solutions

Quality/Regulatory Archive





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