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Medical device Software and Apps – Market access routes in EU and USA
November 1, 2017 @ 09:00 - November 2, 2017 @ 16:00
The course will outline the route to market access in Europe (CE-marking) and US (FDA) for medical devices.
The course will among other items cover the following:
- Challenges for manufacturers and other operators
- New MDR
- Quality management in Software development
- EN 62304/82304
- Risk management acc. to EN 14971
- Usability acc. to EN 62366
- Other useful standards/guidelines
- US regulation
All Ideon companies get a discount,
Day 1 from 09.00-16.00
Day 2 from 09.00-16.00