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

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
About Our Speaker
 Dr. Joy Frestedt
Regulatory & 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-registration-growing-
need-of-clinical-data-pmcf-registries-for-devices