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”
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”
My solo consultancy is geared towards startup medical device companies preparing for quality system lift-off.Continue reading “Quality System Documents & Services”
Subtitle: Buying standards from the Estonian Centre for Standardisation (EVS)
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)”
Continue reading “Sam’s List of FDA Registered Contract Manufacturers & Sterilizers in SF Bay Area”
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”
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”
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”
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”
This should be one of the first questions asked during the medical device development process. Continue reading “What standards apply to my medical device?”