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