ISO 13485:2016 has a broader view of risk management than in the past.
My life’s work, depicted in 2 “quality system interaction” diagrams that are included in my Quality Manual.
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
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
Think global, buy local…and local for me is the San Francisco, California USA area.
Thank you, NAMSA, for preparing this amazing document!
So many people ask me for Notified Body (NB) selection advice that I decided to get a little organized.