Jan-Paul is very experienced in the whole process from start to market introduction, including setting up an ISO 13485 quality system and compiling Technical Files, performing risk-based process validations, submitting international clinical trials and writing clinical evaluations. Experience with broad field of device types including heart-assist devices, cardio-vascular devices, (dental) implants, wound dressings, dialyzers, organ storage, X-ray devices, medical software and apps.
The key expertise areas of Jan-Paul
- Set-up, review & update Quality Systems according to the ISO 13485:2016.
- Technical File Set-up and Review (MDD and MDR).
- Guide companies through the process of Development, incl. Test-house selection, Protocols, and Reports.
- Resolving Notified Body audit findings.
- Internal auditing.
- Provide training on e.g. ISO 13485:2016, Risk Management according to the EN ISO 14971:2012.
- Sterilization Validations on EO and Gamma irradiation.
- Set-up Process-Validations.
- Writing Clinical Evaluations.
- Set-up clinical trials.
- Hands-on approach. Supported several companies from start to market introduction.
- Interim QA and RA manager.
Jan-Paul about working at Qserve
"In every other job, I wanted to change after five years. But not at Qserve, because the work is never dull!".
Prior to Qserve, Jan-Paul was co-founder and Chief Technology Officer for a start-up company developing a Class III heart assist device. Prior to that, he worked on the development of a jaw-joint prosthesis. Jan-Paul holds a Master degree in Biomedical Engineering and a PhD in Medical Sciences. Jan-Paul is the co-author of more than twenty scientific articles and co-inventor of three patented inventions. He is the former secretary of the biomedical department of the Royal Dutch Society of Engineers.
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