Essure Discontinuation Doesn’t Mean the End to FDA Scrutiny

Bayer has already decided to stop selling the controversial birth control device, but FDA says it will continue to monitor the long-term safety of Essure.

Is Progress on MDR and IVDR Happening Fast Enough?

One year into the transition periods for the new EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), industry experts continue to express concern that more progress is needed to help companies prepare for the new regulations within the limited transition period.

8 Things You Should Know about the EU MDRs

Respondents to a recent survey on the new EU regulation raise some concerns about readiness. Are you prepared?

6 Questions to Ask Yourself about ISO 11607 Compliance

These FDA-consensus standards guide packaging design and validation—how compliant are you, and how ready are you for the upcoming revision?

FDA Medical Device Safety Action Plan: Good or Bad for Medtech?

FDA’s five-pronged Medical Devices Safety Action Plan, revealed in April, has triggered concern by AdvaMed, Johnson & Johnson, and physician specialty groups.

Should Medical Devices Come with Expiration Dates?

Implantable medical devices containing highly sophisticated electronics are lasting longer than before, raising the bar for safety and liability.

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Design History File vs. 510(k) vs. Technical File: What Do Medical Device Developers Need to Know?

Design History File vs. 510(k) vs. Technical File: What Do Medical Device Developers Need to Know?

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Is FDA Getting More Cozy with AI?

FDA’s recent approval of stroke detection software paves the way for Artificial Intelligence applications to thrive on the healthcare landscape.

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Get Answers to Your Usability Testing Questions

A live demonstration of formative usability testing at MD&M East aims to share best practices and answer attendee questions.

New EU MDR Regulations and Revamp of the Medical Device Directive

An overview of the key impact points and challenges of European Union Medical Device Regulation.