MDR - Clinical Investigation
What will be the impact of the new Medical Device Regulation on clinical data collection and reporting for Medical Device manufacturers?
To inform and prepare medical device manufacturers, Qserve has created a one-day training to explore the requirements of the new MDR on all aspects of clinical data to managing all parties involved including sites, IRB and CA.
How will the EU MDR impact data collection in the post-market phase? What will be the status of clinical data collected under an Investigator-Initiated Study (ISS)? Does the manufacturer sufficiently control the site? Will there be an opportunity to monitor sites during an ISS? Can ISS clinical data be used to fulfill the Post-market clinical follow-up requirements of a product?
What clinical regulatory requirements will the EU MDR add on top of ISO 141555? A detailed comparison of the two will be discussed
We offer open enrolment, on-location, train-the-trainer formats. Please contact us
to schedule in-house training, which is also recommended for training multiple colleagues or teams at the same time.
: € 875.- / $ 990.-