Who it applies to
- Medical-device software and standalone clinical or diagnostic applications.
- Digital health companies placing regulated software on the EU market.
- Suppliers supporting regulated medical-device workflows.
What you need to do
- Product classification, quality management, risk management, technical documentation, and post-market surveillance.
- Cybersecurity and software lifecycle evidence.
- Traceability between product risk, controls, testing, and changes.
How to use this entry
- Use this page to understand the buyer or regulatory pressure before it becomes a deadline.
- Run the regulation checker to see whether this area is likely to matter for your company now.
- If it becomes relevant, Kaamos can help you scope the gap and turn it into prioritized security work.