To enter the EU market, your SaMD must be developed under a Quality Management System (QMS) that complies with ISO 13485.
What You Need
- ISO 13485: General quality framework
- ISO 14971: Risk management integration
- IEC 62304: Software development lifecycle
Best Practices
- Build your QMS, don’t buy a generic one
- Ensure continuous documentation and audits
- Tie QMS to real clinical risk management
Cybersecurity Integration
Use MDCG 2019-16 as a guideline for secure development. Cybersecurity is considered a safety issue under EU MDR, it is not just IT hygiene.
Learn More:
This post is part of SaMD Europe Launch Guide.
This content has been enhanced by GenAI tools.
