Applied Tissue Technologies’ negative-pressure dressing gets FDA nod

USA – Researchers Call on FDA to Tighten Requirements for Breakthrough Devices

A team of researchers are calling on the US Food and Drug Administration (FDA) to require more evidence and impose stricter limits on medical...
Publication de la norme ISO 11930:2019 sur l'évaluation de la protection antimicrobienne d'un produit cosmétique

USA – ISO Preps for FDA’s Proposed Overhaul of Device Quality System Regulation

A recently proposed US Food and Drug Administration (FDA) rule for harmonizing medical device quality management systems with ISO 13485 is “an important next...
Updated: FDA Warns Zimmer Biomet’s Indiana Plant

USA – Updated: FDA Warns Zimmer Biomet’s Indiana Plant

Zimmer Biomet announced Friday via an SEC filing that it received a warning letter related to observed non-conformities with current good manufacturing practice (CGMP) requirements of...
6 Questions to Ask Yourself about ISO 11607 Compliance

USA – 6 Questions to Ask Yourself about ISO 11607 Compliance

When working in medical device packaging, you should know that ISO 11607-1 and -2 are the recognized guidelines for validating terminally sterilized medical device...
FDA plans to use ISO 13485 for medical devices regulation

USA – FDA plans to use ISO 13485 for medical devices regulation

ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes, is the International Standard for quality management systems for the medical devices sector....
FlexDex Intuitive Laparoscopic Instruments Going on Sale in U.S.

Discovery – FlexDex Intuitive Laparoscopic Instruments Going on Sale in U.S.

Robotic surgical systems, such as those from Intuitive Surgical and TransEnterix, can be prohibitively expensive for many, if not most, hospitals. FlexDex, a company based outside of Detroit,...
Medical Device Validation: What You Need to Know and Why It's Important

USA – Medical Device Validation: What You Need to Know and Why It’s Important

Inadequate process validation is one of the most common issues leading to warnings from the US Food and Drug Administration (FDA). It may also...
New Hip Replacement Procedure Launches

USA – New Hip Replacement Procedure Launches

The first two total hip replacement surgeries using a new 3D technology were recently performed by Gregory Martin, MD, founder of Personalized Orthopedics of...
A Temporary Fix for the EpiPen Crisis?

USA – A Temporary Fix for the EpiPen Crisis?

The ongoing saga of the EpiPen shortage crisis took a new turn today as FDA made a move to extend the expiration dates of...
Release of Guidance Document: Regulatory requirements for Drug Identification Numbers (DINs)

Canada – Health Canada to Adopt IMDRF Table of Contents Format

As part of a push toward regulatory convergence, as of 1 April 2019, medical device manufacturers will be expected to submit premarket applications for...

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