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Medical Device Audits, Certification & Verification Resource Center

Featured Content

March 14, 2018 | By Brian Moan, Norman Rabin

IVDR signals In Vitro Industry Shake-up

Manufacturers must re-evaluate existing regulatory and compliance strategies to meet the new requirements.

November 16, 2017 | By Dr. Christopher Joseph Devine

The DMR: It’s the Recipe, People

The DMR is nothing more than the recipe (a.k.a. secret sauce), while the DHR is documented evidence of compliance.

October 25, 2017 | By Dr. Christopher Joseph Devine

Dr. D Sees a Trend

There really is no excuse for receiving a Form 483 observation for management review.

August 11, 2017 | By Emmanuel Garnier

When Health-Related Apps Qualify as Medical Devices in the European Union

According to the Advocate General’s interpretation of the Directive and related soft law (i.e., MEDEV guidelines), software allowing the prescriber to detect contraindications, drug interactions and excessive doses shall qualify as a medical device.

July 31, 2017 | By Peter Rose

A Smooth Route to the New Medical Device Regulation

The new MDR introduces several changes that manufacturers must consider right away.

See more News at the Medical Device Audits, Certification & Verification Resource Archive ››

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

In the broadcast we’ll outline some of the challenges associated with traditional approaches to regulatory information management, and how a shift to a product-centric vs project-centric approach can make information more accessible and usable across teams and processes.

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