Webinar on Growing need of Clinical Data, PMCF & Registries for Devices

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Growing need of Clinical Data, PMCF Registries
for Devices

• 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

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About Our Speaker

• Dr. Joy FrestedtRegulatory Clinical Expert,
  Medical Device 
• Date Time Wednesday, Nov 15, 2017 11 AM to 12
  noon EST/4 PM to 5 PM CET
• Register here https//www.makrocare.com/webinar-r
  egistration-growing-need-of-clinical-data-pmcf-reg
  istries-for-devices