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Growing need of Clinical Data, PMCF & Registries for Devices

Speaker: Dr. Joy Frestedt

Post Market Clinical Follow Up (PMCF) studies are a critical component of the clinical evidence required to comply with the new European regulations. As Clinical Evidence Reports (CERs) encounter more and more scrutiny by Notified Bodies (NBs), the gaps surrounding past PMCF work are becoming more evident. “Passive” collection of adverse events, complaints and the like may not be sufficient any longer to demonstrate conformity to the Essential Requirements and to the future Medical Device Regulation (MDR). This webinar will review emerging PMCF, Registry needs in this era of pre-MDR business risk evaluations.

Learning objectives:

  • Clearly define PMCF, Registry needs for Devices
  • Apply CER gaps in safety and performance clinical data to PMCF & registry designs
  • Differentiate adequate PMCF plans from less than adequate PMCF plans
  • Alternate methods of getting Clinical data for your Devices