Process Vision exists since 2000 and consists of Willem vd Biggelaar (Curriculum Vitae).
Process Vision offers QA/RA consultancy for medical devices in a lean approach.
Willem works in (medical device) development / production since 1987.
Customers are startups, medium and large companies.
Willem can easily form a bridge between the customer and a notified body because he is also CE/ISO13485 auditor for DEKRA certification and Dare!! Medical Certifications
Willem is also part of a consultancy network.
The QA (Quality Assurance) part
- Role of QA manager
- Setup MDR, ISO13485 & 21CFR820 compliant lean quality systeem
- Ensure to keep the ISO13485 certificate
- Exectue internal & supplier audits
- Guide development and production sites on QA matters
- Guide external audits executed by notified bodies and FDA
The RA (Regulatory Affairs) part
- Rol of RA manager
- Setup submissie files to access markets (e.g. Europe, US)
- Get and keep markets access
- Guide development and production sites on RA matters
- Communicate with notified bodies and FDA
Apart from above Willem offers training in the area of (medical) QA/RA and is he active on conferences and education.
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