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

Process Vision nominated as Best Knowledge Supplier 2019

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

Lees meer...

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.

Lees meer...
Profile

Process Vision exists since 2000 and consists of Willem vd Biggelaar (Curriculum Vitae).
Process Vision offers QA/RA consultancy for medical devices in a lean approach. 
Willem works in (medical device) development / production since 1987.
Customers are startups, medium and large companies.
Willem can easily form a bridge between the customer and a notified body because he is also CE/ISO13485 auditor for DEKRA certification and Dare!! Medical Certifications  
Willem is also part of a consultancy network

  

The QA (Quality Assurance) part 

  • Role of QA manager
  • Setup MDR, ISO13485 & 21CFR820 compliant lean quality systeem 
  • Ensure to keep the ISO13485 certificate
  • Exectue 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

  • Rol of RA manager
  • Setup submissie 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 in the area of  (medical) QA/RA and is he active on conferences and education.

Need more info?
Contact Willem via email (Dit e-mailadres wordt beveiligd tegen spambots. JavaScript dient ingeschakeld te zijn om het te bekijken.) or cellphone / whatsapp (06-12296826)

  

STEL EEN VRAAG
U kunt in onderstaand formulier vrijblijvend uw vraag op het gebied van kwaliteitsmanagement stellen. Wij zullen uw vraag zo spoedig mogelijk beantwoorden.