My solo consultancy is geared towards startup medical device companies preparing for quality system lift-off.
ISO 14971:2019 & Europe MDR Risk Management Process Flow
Trying to understand the “state of the art” in medical device risk management? This diagram attempts to distinguish between ISO and European requirements.
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