Medische CE-Richtlijnen Process Vision Trainingen en Consultancy Process Vision Process Vision
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.

Being 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)

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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.

Read more ...