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Medical device Software and Apps – Market access routes in EU and USA

November 1 @ 09:00 - November 2 @ 16:00

Medtech course

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
  • CE-marking
    • MDD
    • 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
  • Exercises

All Ideon companies get a discount,

Day 1 from 09.00-16.00
Day 2 from 09.00-16.00

Venue

Hellmuth Hertz
Scheelevägen 17
Lund, SE-223 70 Sweden
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