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Anja Wiersma
CEO at mi-CE consultancy

Profile

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.

Agenda Sessions

  • GLOBAL PANEL DISCUSSION: IVD Regulation

    13:20
  • LDT/ in House Developed Tests Requirements under the IVDR

    11:35