Workshop: Software Validation for Medical Products

Content:

• Introduction, terms, and definitions 

• Regulatory requirements (legal, normative)  

• Usability validation: Compliant with IEC 62366-1 and IEC 82304-1 

• Software validation and risk management 

• Documentation requirements (ISO/IEC/IEEE 15289:2019) 

• In-depth analysis using best practice examples 

speaker: Dr. Julian Alpers  

costs: 100€ members, 150€ non-members