- ISO 13485 is a voluntary quality system standard
- Generic in nature
- Management is held accountable for the quality management system
- Appropriate for medical device manufacturers, contract manufacturers, component manufacturers, service providers to the medical device industry
- Largely aligned with FDA’s Quality System Regulation (21 CFR Part 820) but NOT identical. Note that there are key differences and the QSR is more prescriptive but not contradictory.
ADVANCED QUALITY SYSTEM SOLUTIONS
Everything should be made as simple as possible, but not one bit simpler.