Trying to understand the “state of the art” in medical device risk management? This diagram attempts to distinguish between ISO and European requirements.
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”
This should be one of the first questions asked during the medical device development process.
Before you read the vocabulary definitions in ISO 9000:2015 you need to know what the “small words” mean.