While conducting PMCF activities may appear costly and burdensome, this process can be streamlined and even automated through technology.
TORONTO (PRWEB) March 02, 2020
Join this live session on Wednesday, March 11, 2020 at 11am EDT (3pm GMT/UK) with featured speakers Derk Arts, MD, PhD, Founder and CEO of Castor, and Nadine Leistner, PhD, Chief Scientific Officer of MEC-ABC, who will illustrate the steps needed to put together a PMCF plan that will pass Notified Body scrutiny. They will also show how medical device companies can put technology to work to support them with a wide array of PMCF approaches.
Under the Medical Device Regulation (MDR), Post-Market Clinical Follow-Up (PMCF) activities will be mandated as part of medical device surveillance programs. These activities should ultimately ensure patient safety through continuous monitoring of certain medical devices. However, with the MDR scheduled to go into full effect on May 26, 2020, manufacturers are scrambling to prepare for MDR compliance. While conducting PMCF activities may appear costly and burdensome, this process can be streamlined and even automated through technology.
Topics to be discussed include:
- Analysis of existing clinical data (clinical evaluation and instruction for use)
- Performing claim analysis and PMCF parameter deduction
- Selecting a PMCF approach and enrollment strategy
- Selecting a platform that suits the approach
For more information or to register for this free event, visit PMCF Success Story: A step-by-step tutorial on creating an approved PMCF plan.
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