October 12, 2017

Medical Device Single Audit Program: The Basics

Holding Globe in One Hand

Recently, the Regulatory Authority Council issued a report that the Medical Device Single Audit Program (MDSAP) has been successful in its pilot, and will therefore continue. So what is the MDSAP and why is it important? (more…)

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October 4, 2017

What the FDA Reauthorization Act Means for Pharmaceuticals and Medical Devices

Signing document

On August 18th, President Trump signed the FDA Reauthorization Act (FDARA). Besides reauthorizing user fees for pharmaceuticals and medical devices for five years the law also focuses on many aspects of device regulation. (more…)

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[WEBINAR] How to Assess Your CER for MDR Readiness Part 1: State of the Art, Safety & Performance Criteria, Equivalence and Systematic Literature Review

Join our President, Laurie Mitchell, on April 29, 2020, at 11AM PST / 2PM EST to align your CER with some key MDR requirements. This live webinar will help you assess your CER and identify possible gaps for mitigation before submission.

Attendees are eligible for a free consultation and scan of their CER (or CER template). Spots are limited – click to register for this free webinar.