Software Design for Medical Devices 2019 (SDMD) – Conclusions
On a two-days conference format and 100 attendances, the event covers some of the most significant and concerning topics in Medical Devices development: EN62304, FDA regulation, and cybersecurity.
- Medical Device manufacturers are very focused on regulatory affairs. MDD to MDR & IVD to IVR transition are to be big challenges.
- Security in Medical Devices has become critical. Risk management must be considered.
- Agile development for medical devices is fully compatible with FDA or EN62304 SW life cycle if applied in the correct way.
- Machine learning & Deep learning is already here, however there is no regulation at all for Medical Devices.