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09 - 10 Nov 2020Ended

Fundamentals of EU MDR and IVDR – Level 1

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Estimated Turnout

30
Delegates

15 Exhibitors

Editions

09 - 10 Nov 2020

Frequency

One-time
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This 2 day seminar will go into the specifics of the European Union Medical Device Regulation (EU MDR) and the In Vitro Diagnostic Device Regulation ( .. Read more IVDR), provide case studies and share lessons learned so your organization can benefit from the mistakes of others.We will review the latest changes to the regulations effective and in force for 2020 and will draw out key developments and key dates with particular emphasis on requirements for US firms shipping materials, parts, and products to the European Union.

Highlights

  • Reasons for the Medical Device Regulation
  • Structure and objectives of the MDR
  • Difference between the old requirements (MDD) and the new (MDR)
  • How to transition from the old directives to the new regulation
  • General safety and performance requirements (GSPR Annex 1)
1899 USD Visitor/General One Dial-in One Attendee
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