Process Vision | Lean Medical Device Quality & Regulatory Services

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

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.