Anja Wiersma PhD

Dr. Anja Wiersma has been an RA/QA consultant for medical device and in vitro diagnostic device manufacturers since 2010. She also acts as a contractor for several notified bodies executing design dossier reviews and CE audits as well as for executing inspections for independent organisations.

Dr. Wiersma is fully qualified as a notified body auditor for all 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 In Vitro Diagnostic Device Regulation (IVDR 2017/746). After working for 8 years at a multinational Pharmaceutical company (Organon), first, as a 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 for 6.5 years. From 2013 until 2015 she was a part-time QA/RA director and part of the management team of an IVD company in the Netherlands.

Since March 2015 dr. Wiersma is a board member 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. As of September 2017, she is a member of the REC as well (RAPS European Council). Dr. Anja Wiersma is a medical biologist by training with a PhD in the neuropharmacological–behavioral – Physiology field.