Exemplar LINK Profile

My motto is - business first before regulations - I got familiar with medical devices as co-founder of Cortrium. Here I managed to certify an ECG monitoring system that was linked to payers' reimbursement schemes. Since 2018 I have assisted manufacturers on the product development journey for CE mark and ISO 13485 certification. Across various medical devices, I know about needed technical documentation, clinical evaluation and QMS but with the business side approach. Without setting business first, there will be no company to audit, and no patients to provide treatment or diagnosing.