Hi
I'm a trainee in regulatiuon and quality management system. I'm asked to do the clinical evaluation for a medical device
Does any one have an exemple or template of (regarding to the recommendation of the Meddev 2.7/1 révision 4 and new EU regulation) :
- a clinical investigation procedure
- a clinical evaluation and post market clinical follow up procedure
- clinical evaluation report
thank you.
I'm a trainee in regulatiuon and quality management system. I'm asked to do the clinical evaluation for a medical device
Does any one have an exemple or template of (regarding to the recommendation of the Meddev 2.7/1 révision 4 and new EU regulation) :
- a clinical investigation procedure
- a clinical evaluation and post market clinical follow up procedure
- clinical evaluation report
thank you.