Education and Training

On-Site Workshops:
"The NEW CE MARKING" MDR/IVDR implementation

Train your whole team with our tailor-made workshops - in Your Offices, with Our Team!

Throughout the year, MDSS organizes events to provide learning opportunities to our clients. Given the new medical regulations that are coming into place (MDR (EU) 2017/745 & IVDR (EU) 2017/746), it is more important than ever to provide our clients with all relevant information to enable them to cope with the new regulations.

Book now to make sure you’re ready to survive and thrive!

MDR Regulation

1 day In-House workshop
Price: $4,500

SUGGESTED TOPICS

  • MDR Compliance Strategy for your Company based on product portfolio
  • The new regulatory system – an overview
  • Classification and Conformity Assessment (Chapter V, Annex VIII (Classification) and IX to XI (Conformity Assessment)) Application on High-Risk class product!
  • Timeline for implementation, New legal aspects, Other aspects (Chapter II, X)
  • Post-Market surveillance (PMS) and Vigilance (Chapter VII, Annex III)

Or customize the topics according to you company needs!

MDR/IVDR Regulation

2 days In-House workshop
Price: $7,000

SUGGESTED TOPICS

  • MDR Compliance Strategy for your Company based on product portfolio
  • The new regulatory system – an overview
  • Classification and Conformity Assessment (Chapter V, Annex VIII (Classification) and IX to XI (Conformity Assessment)) Application on High-Risk class product!
  • Notified body and Certificates issued by notified bodies, CE Marking of conformity and Declaration of Conformity (Chapter IV, Annex IV, V, VII, XII)
  • Post-Market surveillance (PMS) and Vigilance (Chapter VII, Annex III)
  • Member states cooperation, Medical Device Coordination Group, Experts laboratories, Experts Panels, Eudamed and UDI (Chapter III, VIII, Annex V)
  • Technical Documentation, Clinical Evaluation, Clinical Investigation Post-Market Clinical follow up (PMCF) (Chapter VI, Annex I, XIV, XV)
  • Timeline for implementation, New legal aspects, Other aspects (Chapter II, X)

Or customize the topics according to you company needs!

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