An updated guidance from the Medical Device Coordination Group (MDCG) explains the modifications that can be made to devices certified under the legacy regulatory system without rendering the device ineligible for the EU market.
ENZYME BLOGAnalyzing the latest developments in regulatory, compliance, and quality
Electronic Quality Management System
Enzyme eQMS is flexible and scalable, making it easy to use for startups, yet configurable to meet the needs of the most complex enterprise
