Process Vision BV is established in 2000 and offers lean QA/RA services for
- Medical Device Development
- Medical Device Production
- Medical Device Market access
Customers are start-ups, medium and large medical device (related) companies.
Process Vision consists of Willem vd Biggelaar,
Having been an ISO13485/CE auditor for DEKRA & Dare!!,
The QA (Quality Assurance) part
- Role of QA manager
- Setup MDR, ISO13485 & 21CFR820 compliant quality system
- Ensure keeping ISO13485 certificate
- Execute 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
- Role of RA manager
- Setup technical 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 courses in the area of medical QA/RA.
He is also active on conferences and education.
Willem is part of a consultancy network for knowledge and resource sharing.
Need more info?
or cell phone / WhatsApp 06-12296826