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”
Think global, buy local…and local for me is the San Francisco, California USA area.
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.
This should be one of the first questions asked during the medical device development process.
The Annex I “Essential Requirements” of the European medical device directives have been supercharged and reincarnated
ISO 13485:2016 has a broader view of risk management than in the past.
ISO 13485:2016 has a broader view of risk management than in the past. Risks are to be considered in terms of the impact on medical device safety and performance, and in terms of meeting regulatory requirements. For managing quality system process risks, rather than adding a “Risk” section to each Standard Operating Procedure (SOP) as some haveContinue reading “ISO 13485:2016 Quality System Process Risk Management”
I can think of 3 options when engineering specification (design verification spec) is not met.
Unfortunately, there is currently no centralized database to search Notified Bodies and their Client companies. Here are some ideas for how to go about this.
Notified Bodies are no longer fighting for your attention – you need to fight for their attention!