Our Team Members
Anja Wiersma, PhD
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) . She has full scope qualifications including Annex II and from low Class I, to high risk Class III devices, with her special expertise on borderline products for MDD as well as full scope qualifications for the IVDD including Annex IV. 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.
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). Anja is an associate partner of Eagle Rock Life Sciences with focus on medical devices/IVD’s regulatory compliances as well as medical device quality management systems and auditing for CE-marking and FDA compliance (QSIT-21CFR820).