- 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 USD (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.