Date: Monday 16th of October
Location: Amsterdam, Novotel Amsterdam Schiphol Airport, Taurusavenue 12, 2132 LS Hoofddorp
Language: Presentations will be in English
Subsciption for: Day pass €400,-
The 16th of October will be the 8th EU MDR Compliance workshop session. The topic of this session is: Combination products.
Dr. ir Gert Bos, EU-MDR specialist and leading Qserve’s efforts around the EU-MDR will moderate the sessions. He will bring the audience up to speed with the latest developments. During the workshop in the afternoon, Gert will present a hypothetical manufacturer, and the attendees will be trained on best practices how, when, and what to implement for compliance with EU-MDR.
The day will be closed with an interactive panel discussion where you can ask our speakers all you want to know for the implementation of the EU-MDR.
Participation in all 10 sessions will ensure your company has the tools to implement EU-MDR compliance within your organization, in a practical approach. Alternatively, you can choose to select topics or join specific sessions of particular interest to your company. More information: European MDR workshop program
Sophie Tabutin, Certification Lead, Active Medical Devices at BSI
Janine Jamieson, from JCombinations AB
Gert Bos, Executive director & Partner at Qserve
9:15 Welcome Coffee/Tea
9:30 Introduction (Gert Bos)
9:45 What is the process for combination devices, how will it change in the MDR and how will the Notified Body react. Scrutiny process, drug agency, how will Notified Bodies help to align. (Sophie Tabutin)
11:15 Janine will present "Experiences as regulator, looking back and forward to make use of MDR (Janine Jamieson)
13:00 Gert will present "Pre-consultation importance, Scientific consultation, what is the process consultations?" (Gert Bos)
16:30 Panel discussion
17:15 Concluding remarks and closure (Gert Bos)
More information about our Qserve experts: