Sector

International Standards

3 compliance framework entries tagged under this sector. Open each card for official documentation links.

3 frameworks

IEC 62366

IEC 62366 Usability Engineering Assessment

Evaluate medical device usability engineering per IEC 62366-1:2015, covering user interface design, formative and summative usability testing, and …

International Standards Medtech

ISO 14971

Official

ISO 14971 Risk Management Assessment

Evaluate medical device risk management per ISO 14971:2019, covering risk analysis, risk evaluation, risk control, and post-production risk monitoring …

International Standards Medtech

ISO 62304

Official

ISO 62304 Software Lifecycle Assessment

Evaluate medical device software development per ISO 62304:2006/AMD1:2015, covering software safety classification, development processes, risk …

International Standards Medtech