2 days On-Site Workshop:
THE NEW CE MARKING, MDR/IVDR Implementation

MDR/IVDR implementation

2 days On-Site Workshop
Price: $7,000

(cost for 2 days’ workshop including all expenses (e.g. workshop, travelling, accommodation))

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

SUGGESTED TOPICS

  • MDR Compliance Strategy for your Company based on product portfolio
  • The new regulatory system – an overview
    • Economic Operators (Manufacturer, Authorized Representative, Importer and Distributors) Scope and definitions (Chapter I, II, Annex XVI)
  • Classification, Conformity Assessment and Quality System requirements (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), Vigilance and Market Surveillance (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)

BENEFITS FOR THE COMPANY

  • Workshop will be develop according to your needs
  • Presentation will be structured to answer specific questions
  • Reduce costs of travel and accommodations (we come to you!)
  • Convenient since you pick the date of the workshop*
  • Up to 20 participants
  • Guidance of new regulations for key persons

MDSS REQUIREMENTS

  • A projector and screen for the designated conference room
  • 50 % deposit upon agreement of date
  • Once flight has been booked, deposit is non-refundable

Please contact us for further information or for more training opportunities in your area! We will immediately provide further details.

Request 2 days workshop now!

MDR Regulation

1 day On-Site Workshop
Price: $4,500

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