My solo consultancy is geared towards startup medical device companies preparing for quality system lift-off.
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
Looking for Medical Device EC-REP? (European Authorized Representative)
In August 2018, I did a survey of some European Authorized Representatives via email.