MDR- Clinical Investigation

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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

Learning objectives

  • How to deal with clinical requirements in the MDR. Start point is your current intended use. What do you claim, want to claim, how is this related to risk management and how do you know if your current data is sufficient?
  • We will focus to practically looking at the data you have to support your claims. If more data is needed what are the options?
  • How can you practically set up a study for more data using current documentation?
  • How to write rationales taking into account the upcoming requirements
  • PMCF requirements

Who should attend?

  • RA professionals
  • Clinical Affairs professionals

Costs

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.

Costs: € 875.- / $ 990.-

How can we help you? Contact us