Antwerp Metropolitan Area
Versatile Medical Doctor with a strong foundation in intrahospital care, humanitarian aid, medical device regulation, and fundamental research. Driven by a deep curiosity for continuous learning and innovation.
• NB's Internal Clinician and Final Clinical Reviewer as per NBOG’s Best Practice Guide 2017-2. • To act as the primary clinical expertise within SGS Medical Device (MD) certification activities • To provide clinical oversight (clinical final review) of clinical assessment performed by SGS, to ensure clinical assessment of the technical documentation conducted under MDD 93/42/EEC and MDR Regulation (EU) 2017/745 are clinically sound • To act as the clinical interface between SGS and subcontracted clinical experts for specific expert reviews of clinical data. • Scientifically evaluate and, if necessary, challenge the clinical evaluation presented, and the results of external clinical experts’ assessment of the manufacturers’ clinical evaluation.
As a member of the SGS Medical Device Certification Clinical Team, I assess the clinical evaluation of medical devices. I apply my scientific, clinical, and in-hospital experience in accordance with MDR regulations and relevant standards, including MDCG, MEDDEV guidelines, and harmonized standards. My goal is to ensure that product reviews are clinically sound and compliant with regulations. I am experienced in evaluating CER, CEP, SSCP, PSUR, CIP, CIR, RM, PMSP, PMCF, and more, ensuring that the medical devices are in conformity with the relevant GSPRs and regulatory compliance.