Process Vision | Lean Medical Device Quality & Regulatory Services

Profile

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,
see Curriculum Vitae and Qualifications

Having been an ISO13485/CE auditor for 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

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

NEWS

Process Vision nominated as Best Knowledge Supplier 2019

Process Vision is door Preceyes genomineerd als Best Knowledge Supplier 2019 (Link Magazine)

New Documentary Film Is Scathing Indictment Of FDA's Regulation Of Medical Devices

Check this out

Scathing Indictmetn of FDA's regulation

4 Keys To Choosing The Right Regulatory Consultant

4 Keys To Choosing The Right Regulatory Consultant

By Bob Marshall, , Chief Editor, Med Device Online

I spent the first two decades of my medical device career with startups and larger OEMs, working with or hiring consultants, as needed, for support. I then became a consultant for seven years, and I saw outsourced support from the other side. Now, 18 months into my tenure as chief editor of Med Device Online, I want to share some perspective on outsourced support. These important relationships can make or break your business.