- 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
*Please provide us with two dates to choose from.
Cost: 7.000€ (Euro) Cost for 2 days' workshop including all expenses (e.g. workshop, travelling, accommodation).
- 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.