About mi-CE

mi-CE consultancyis a consultancy with special experience in regulatory requirements for In Vitro Diagnostic Devices, all kinds of Medical Devices, including the so-called "borderline devices" and clinical evaluations.

Anja Wiersma, PhD : CEO and senior consultant

• Anja Wiersma, is a medical biologist by training with a PhD in the NeuroPharmabehaviour Physiology field. After working for 8 years in a multinational Pharmaceutical company, first as scientific researcher and later as a Strategist in Strategy and Business Development department, she started to work for a Notified Body for medical devices and IVDD. She was working for this notified body for 6.5 years. In the last position she was a certification manager for IVDD and for ISO 13485:2003.
  
  She is fully qualified as a notified body auditor for MDD full scope including Annex II and from low Class I, to high risk Class III devices, with her special expertise on borderline products. Furthermore she is qualified for IVDD with the full scope. Additional she is a lead auditor for the QMS standard ISO 9001 and ISO 13485, including the requirements needed for Canadian approval (CMDCAS) and Taiwanese compliances.  

She started her own consultancy mi-CE consultancy for medical device and in vitro diagnostic device manufacturers, and remains a contractor for notified bodies executing design dossier reviews, CE audits and QMS audits.