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?
Contact Willem via email This email address is being protected from spambots. You need JavaScript enabled to view it.
or cell phone / WhatsApp 06-12296826