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

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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.

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Profile

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

Apart from above Willem offers training courses in the area of  (medical) QA/RA and is he active on conferences and education. Willem is also part of a consultancy network

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)

 

 

 

 

  

ASK A QUESTION
If you have a medical device quality or regulatory related question, feel free to ask.