MakroCare is organizing the webinar on Growing need of Clinical Data, PMCF & Registries for Devices.This webinar will review emerging PMCF, Registry needs in this era of pre-MDR business risk evaluations.

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).

Learning objectives:

Tick Bullet Clearly define PMCF, Registry needs for Devices

Tick Bullet Apply CER gaps in safety and performance clinical data to PMCF & registry designs

Tick Bullet Differentiate adequate PMCF plans from less than adequate PMCF plans

Tick Bullet Alternate methods of getting Clinical data for your Devices

Speaker:

Dr. Joy Frestedt
Regulatory & Clinical Expert, Medical Device

Date & Time: Wednesday, Nov 15, 2017 , 11 AM | 5 PM CET