About us

About us

mi-CE consultancy has consultants (with PhDs and MDs) 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.

 

The management team consist of: Anja Wiersma and Siert Knollema

 

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.

     

    Siert Knollema, MD, PhD, Msc : senior clinical consultant

     

    • Siert Knollema is a molecular medical biologist with a PhD in molecular stroke research. He is also a medical doctor with specialization in nuclear medicine and presently working for 6 hospitals. His sub-specialization is cardiology and oncology. The main hospital he is consulting to is the Isala clinics; the largest non-academic hospital of the Netherlands. 

      Since 2005 he is manager of the department of nuclear medicine of the Isala clinics. In this role he is solely responsible for the department consisting of 26 FTE. Besides that he is one of the initiators and managers of the new imaging department which consists of the former radiology and nuclear medicine department and  in which 170 FTE are working. 

      He is also one of the medical doctors which, by law, have to be a member of the Medical Ethical review committee (METC). Besides that he is one of the architects of a newly to be erected department which is specializing in clinical trails for medical device companies.

    For mi-CE consultancy he is the clinical expert and senior consultant dedicated for clinical evaluations, reviews and clinical pathway analysis.