Nice shirt, good video. This is an important topic for new MDR submission in the device, IVDR and combination product space. Would be worth a deep dive to discuss the differences between device requirements when compared to combination product requirements pertaining to Tech File content.
Monir you are doing the best job ever!
Ths for many good examples. Perhaps it helps with some slides...
Excellent presentation about technical documentation requirements.
For Validation…Upto how many months data is required to file for Technical Documentation review?
Nice shirt, good video. This is an important topic for new MDR submission in the device, IVDR and combination product space. Would be worth a deep dive to discuss the differences between device requirements when compared to combination product requirements pertaining to Tech File content.
Good point. Maybe another episode to focus on that.