Online workshop: Lessons learned on the new MDR for medical devices!
A more in-depth / advanced MDR workshop based on practical examples of the attendants
One day after the final date of application of the Medical Device Regulation (EU 2017/745) this workshop will start with a brief presentation on the updates of the MDR and guidance documentation, the status of the designation of the Notified Bodies & the status on the initial audits under the MDR.
Additionally, the workshop will focus on a selection of important topics of the MDR. Attendants may choice which topics they would like to discuss in detail, like:
1. Clinical evaluation process: What is enough data? How to gather the data?
2. Post Market Surveillance process (including PMS plan, PSURs, PMCF)
3. Eudamed/UDI; Registration
4. How to prepare an initial MDR audit; What to expect?
5. Risk Management process
6. Other topics …
You will get an insight in how you can comply with the MDR requirements regarding the implementation of the Technical Documentation of your devices and the Quality Management System of your company.
The approach of the workshop is to have an interactive & in-depth discussion with the attendance using practical examples. The attendance will leave with more knowledge on the practical implementation of specific MDR requirements.
Presenter Anja Wiersma, is a medical biologist by training with a PhD in the NeuroPharmacological –Behavioural – Physiology field. After working for 8 years at a multinational Pharmaceutical company (Organon), she started to work for a Notified Body in the field of Medical Devices and In Vitro Diagnostic Medical Devices. She was working for this notified body for 6.5 years.
She is fully qualified as a notified body auditor for the Medical Device Directive (MDD 93/42/EEC); Medical Device Regulation (MDR EU 2017/745); the In Vitro Diagnostic Device Directive (IVDD 98/79/EC) and In Vitro Diagnostic Device Regulation (IVDR 2017/746).
Since 2010 she is a RA/QA consultant at mi-CE consultancy for medical device and in vitro diagnostic device manufacturers, and she remains a contractor for several notified bodies executing design dossier reviews and CE audits as well as for executing inspections for independent organisations.
Since March 2015 she is member in the board of the RAPS Netherlands Chapter. RAPS is the Regulatory Affairs Professional Society. As of March 2017, she is the chair of the board of the RAPS Netherlands Chapter. And as of September 2017, she is a member of the REC as well (RAPS European Council).
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This workshop is in English and is free of charge. We welcome new contacts, so feel free to share this invite with your network!