My solo consultancy is geared towards startup medical device companies preparing for quality system lift-off.
Category: ISO 13485
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
Transitioning to ISO 13485:2016
Now is the time to get the 13485 monkey off your back.
Quality Policy and Objectives
Does your organization’s Quality Policy inspire you, or tire you? Are you Quality Objectives follow a framework established by the Policy statement?
Independence Matters
Independence is the basis for judicial systems and sporting matches. And for quality systems, it is generally accepted that personnel who are independent of an