Process Vision (established since 2000) consists of Willem vd Biggelaar (Curriculum Vitae) and offers lean QA/RA consultancy on medical device development / production / market access. Customers are start-ups, medium and large companies. Being an ISO13485/CE auditor (DEKRA, Dare!!), Willem can easily form a bridge between customer and notified body.
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
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