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

Process Vision offers a large scale of courses / workshops on medical devices. Each course / workshop can be adapted to the customer wishes. The default list is given below. 

  • Medical Device Regulatory introduction
  • How to bring your device to the EU market (CE)
  • How to bring your device to the US market (FDA)
  • How to design a lean but compliant Quality Management System
  • ISO13485 Quality Management System for medical devices
  • ISO13485 Auditor
  • ISO14971 Risk Management for medical devices
  • IEC62366 Usability Engineering for medical devices
  • IEC62304 Software development for medical devices
  • IEC60601 Basic Safety & Essential Performance for medical electrical equipment
  • Medical Device Regulation (MDR)
  • FDA 21CFR part 820 Quality System Regulations
  • FDA 21CFR part 11 Electronic records and Electronic Signatures

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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