Date 4-5 July 2017
Location: Sofitel EU, Brussels (Belgium)
Gert Bos, executive Director, and Partner at Qserve is invited as a speaker at RAPS EU Medical Device/ In-Vitro-Diagnostics Regulations in Brussels.
He will be presenting Conformity Assessment Now and Then on the 4th of July and Additional Regulation Requirements, Scrutiny and Consultations, Implementing and Delegated Act; Transition Timing on the 5th of July.
Conformity Assessment Now and Then objectives:
- Routes to CE marking and conformity assessment under the MDD and the value of ISO 13485
- How the MDR changes conformity assessment
- Additional MDR QMS requirements
Additional Regulation Requirements, Scrutiny and Consultations, Implementing and Delegated Act; Transition Timing objectives:
- Additional scrutiny of high novel risk
- What is expected to follow the MDR/IVDR in delegated acts
- Requirements for transitioning CE marking from the directives to regulations
Only RAPS brings together the leading industry experts, regulators and Notified Bodies who have been tracking the evolution of the MDR and IVDR from the beginning. Now we want to connect you with the world's largest community of regulatory professionals to fully understand the texts and hash out the challenges of tracking and implementing the new requirements. RAPS is here to help you prepare for the changes and understand the impact on your organization's regulatory resources.
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