Skip to main content
RAPS Euro Convergence 2024 Main banner
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.
Presentation Icons
Ticketed Event
Ticketed Event
Sponsored Presentation
Sponsored Presentation
Learning Level: Foundational
Learning Level: Foundational
New Exhibitor
New Exhibitor
Networking Event
Networking Event
Enterprise Network Member
Enterprise Network Member
Learning Level: Expert
Learning Level: Expert
Learning Level: Advanced
Learning Level: Advanced
Learning Level: Intermediate
Learning Level: Intermediate
Back

Anja Wiersma, PhD

CEO / senior consultant
mi-CE consultancy

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), first as scientific researcher and later as a Strategist in Strategy and Business Development department, 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) and the In Vitro Diagnostic Device Directive (IVDD 98/79/EC) and for the In Vitro Diagnostic Device Regulation (IVDR EU 2017/746).
Since 2010 she is a RA/QA consultant for medical device and in vitro diagnostic device manufacturers, and she remains a contractor for several notified bodies executing design dossier reviews and CE and ISO 13485 audits as well as for executing inspections for independent organisations.
Furthermore, as of Jan 2013 until Aug 2015 she was a part time QA/RA director and part of management team of an IVD company in the Netherlands.

Since March 2015 she is member in the board of the RAPS Netherlands Chapter. As of March 2017, she is the chair of the board of the RAPS Netherlands Chapter. And as of September 2017 until September 2020, she was a member of the REC as well (RAPS European Council).

Disclosure information not submitted.

Presentation(s):