ISO 13485:2016 has a broader view of risk management than in the past.
SAM’s Quality System Process Interactions
My life’s work, depicted in 2 “quality system interaction” diagrams that are included in my Quality Manual.
European Medical Device Standards: 2019-02-02
Sane people use their Saturday mornings for household tasks, lawn-mowing or catching up on sleep. Not me! I have a weekly appointment with myself that
ISO IEC EN Standards Hacks, Tips, Tricks
Subtitle: Buying standards from the Estonian Centre for Standardisation (EVS) EVS is the national standards body in Estonia. Since Estonia is a member of the European Union
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.