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Quality/Regulatory

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
No Comments

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

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June 15, 2022

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

By MedTech Intelligence Staff
No Comments

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.

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Garrett Schumacher
June 15, 2022
Garrett Schumacher

The Shifting Sands of Medical Device Cybersecurity Regulation

By Garrett Schumacher
No Comments

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.

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Hand holding globe - diversity
June 8, 2022
Hand holding globe - diversity

AdvaMed Releases New Resource on Diversity in Clinical Research

By MedTech Intelligence Staff
No Comments

“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.

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Medical device recall
June 8, 2022
Medical device recall

Medtronic Recalls HVAD Pump Implant Kit for Pump Weld Defect

No Comments

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.

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Lisa Hedges
June 7, 2022
Lisa Hedges

Optimizing Wearables

By Lisa Hedges
No Comments

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

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Sherry Parker, WuXi AppTec
June 7, 2022
Sherry Parker, WuXi AppTec

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

By Sherry Parker, Ph.D.
No Comments

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.

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Bernstein_Mazur
June 1, 2022
Bernstein_Mazur

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

By Stephen Bernstein, Lisa Mazur
No Comments

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.

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May 31, 2022

FDA CDRH Announces Reopening for All IVD Pre-Submissions

By MedTech Intelligence Staff
No Comments

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

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Device Labeling MedAccred
May 31, 2022
Device Labeling MedAccred

MedAccred Program to Develop Labeling, Printing and UDI Audit Criteria Launched

By MedTech Intelligence Staff
No Comments

“The MedAccred Labeling, Printing and UDI Task Group’s role is to provide medical device companies with structure and requirements to assist in identifying and implementing industry best practices for global market compliance.”

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