My solo consultancy is geared towards startup medical device companies preparing for quality system blast-off.Continue reading “Quality System Documents & Services”
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.
Continue reading “ISO 14971:2019 & Europe MDR Risk Management Process Flow”
ISO IEC EN Standards Hacks, Tips, Tricks
Subtitle: Buying standards from the Estonian Centre for Standardisation (EVS)
(the standard identification number 12345 and the Euro amounts are fictitious)
(the standard identification 54321 and the Euro amounts are fictitious)
Looking for Medical Device EC-REP? (European Authorized Representative)
In August 2018, I did a survey of some European Authorized Representatives via email.
Continue reading “Looking for Medical Device EC-REP? (European Authorized Representative)”
Sam’s List of FDA Registered Contract Manufacturers & Sterilizers in SF Bay Area
Continue reading “Sam’s List of FDA Registered Contract Manufacturers & Sterilizers in SF Bay Area”
Notified Body Selection Guide
So many people ask me for Notified Body (NB) selection advice that I decided to get a little organized. Continue reading “Notified Body Selection Guide”
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.Continue reading “Clinical evaluation & investigation in Europe MDR”
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.Continue reading “Europe Clinical Evaluation Guidelines SmackDown”
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 WRONG.Continue reading “Risk flowchart you won’t find in EN ISO 14971:2012”
What standards apply to my medical device?
This should be one of the first questions asked during the medical device development process. Continue reading “What standards apply to my medical device?”