Anja WiersmaCEO at mi-CE consultancy
Anja Wiersma, is a medical biologist by training with a PhD. 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 both the MDD (93/42/EEC); MDR (EU 2017/745) and the IVDD (98/79/EC) and 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 file reviews and CE and ISO 13485 audits. Furthermore, as of Jan 2013 until Aug 2015 she was a part time QA/RA director and member of management team of an IVD company in the Netherlands. Since March 2015 she is member and later chair of the board of the RAPS Netherlands Chapter.