We can provide you both online and onsite training on a variety of subjects concerning regulatory and quality assurance/control.
We have readymade programmes on the following topics which can be immediately delivered:
- ISO13485 standard interpretation
- Writing Clinical Evaluation Reports
- Risk Management as per ISO14971
- EU MDR
- Indian MDR
- US FDA regulations for medical devices
- Statistical Process Control
- Capability Analysis
- Root Cause Analysis and Investigation Methods
- Usability Engineering
- Writing Biological Evaluation Plans and Reports
- Post Market Surveillance Activities
Besides the above, we can also develop specific programmes as per your need using our subject matter experts.