Chair of Board of RAPS Netherlands Chapter, CEO of 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 both the Medical Device Directive (MDD 93/42/EEC) and the In Vitro Diagnostic Device Directive (IVDD 98/79/EC).
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 audits. She is also specialized regulatory and QMS consultant with regard to the medical device regulatory requirements for FDA. (510(k) DHF approvals and compliance to 21CFR820).
Since March 2015 she is member in the board of the RAPS Netherlands Chapter. As of March 2017 she became the chair of the board of the RAPS Netherlands Chapter.
And as of September 2017 she is a member of the REC (RAPS European Council).
Saturday, September 21
9:00 AM – 5:00 PM