Trying to understand the “state of the art” in medical device risk management? This diagram attempts to distinguish between ISO and European requirements.
Author Archives: Sam Lazzara
Quality System Documents & Services
My solo consultancy is geared towards startup medical device companies preparing for quality system lift-off.
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 they will publish ISO / IEC and CEN / CENELEC standards with the “EVS-” prefix added to the front of the designation See examples below. Example A – ISO Standards (the standard identification number 12345 and the EuroContinue reading “ISO IEC EN Standards Hacks, Tips, Tricks”
Looking for Medical Device EC-REP? (European Authorized Representative)
In August 2018, I did a survey of some European Authorized Representatives via email.
Sam’s List of FDA Registered Contract Manufacturers & Sterilizers in SF Bay Area
Think global, buy local…and local for me is the San Francisco, California USA area.
Notified Body Selection Guide
So many people ask me for Notified Body (NB) selection advice that I decided to get a little organized.
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.
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.
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.
What standards apply to my medical device?
This should be one of the first questions asked during the medical device development process.
