Early access registrations are open for Headstart, a predictable, fixed-price program for becoming compliant.

Meta-Documents

IEC 62304:2006

ISO 14971:2019

IEC 62366-1:2015

ISO 13485:2016

Clinical Evaluation

Performance Evaluation

Data Protection (GDPR)

No Cookie For You Privacy Policy Imprint
No QMS on this planet will save you from creating crappy software.