Does your ISO 13485:2016 upgrade project need a power-boost?
ISO 13485:2016 QMS Process Risk Management
ISO 13485:2016 has a broader view of risk management than in the past.
Sam’s List of FDA Registered Contract Manufacturers & Sterilizers in SF Bay Area
Think global, buy local…and local for me is the San Francisco, California USA area.
Europe MDR & IVDR on Steroids
Thank you, NAMSA, for preparing this amazing document!
Notified Body Selection Guide
So many people ask me for Notified Body (NB) selection advice that I decided to get a little organized.
Clinical evaluation & investigation in Europe MDR
Want a good career with lots of job security? Learn how to perform clinical evaluations or run clinical investigations.
Europe Clinical Evaluation Guidelines SmackDown
The European Commission’s medical device conniption reached a frenzied pitch with the release of the Medical Devices Regulation (MDR) 745/2017 in May 2017.
Risk flowchart you won’t find in EN ISO 14971:2012
If you are concerned about marketing your devices in Europe, don’t be fooled by the flowchart in the international version of ISO 14971:2007. It is