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.

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Upcoming Events & Webinars

May 1, 2018 – May 2, 2018

Medical Cybersecurity: Vulnerability and Patch Management

This conference brings together leading experts from FDA, the medical device industry, hospitals, and independent consultants to share experiences and discuss strategies and best practices for designing and evaluating secure technologies and ensuring system and patient safety.

May 14, 2018 – May 15, 2018

Medical Device Recalls: Current Topics and New Initiatives

Join the sixth annual MedTech Intelligence Medical Device Recalls conference for presentations, panel discussions, and networking with senior FDA and industry experts to learn about recent and upcoming changes and their practical impact on how companies manage the decision-making and execution of recalls.