Meet the founder

I founded Villa Medica after more than 28 years working at KEMA Quality, which later became part of DEKRA, and at DEKRA Certification B.V., a Dutch Notified Body.

I studied Polymer Science and Biomedical Engineering at the University of Twente in the Netherlands. During my career, I held a range of roles, including:

• Certification management at KEMA Quality.
• Technical documentation review for higher- and lower-risk medical devices under Directive 93/42/EEC and Regulation (EU) 2017/745.
• Lead auditor for ISO 13485:2016, MDSAP, the Singapore Accreditation Council (SAC) scheme and Taiwan’s TCP III.
• Project management for medical devices, with a focus on cardiovascular and neurovascular devices, wound dressings and ophthalmic devices.

I have worked with manufacturers in Europe, China, the United States, Singapore and other international markets. My experience also covers manufacturing processes such as injection moulding, extrusion, hydrophilic coating, manual assembly, drug coating, stent cutting and related post-processing.