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PMCF Surveys New Product Icon 

REGULATORY & QUALITY SOLUTIONS (R&Q)

Booth: 206

The R&Q EU MDR expert team has developed a PMCF survey process that is holistic and flexible around medical device manufacturers’ needs as part of an “end-to-end” PMS solution, including the critical task of managing NB expectations. R&Q’s holistic approach is based on inter-dependent processes of Risk Management, Clinical evaluation and Post Market Surveillance. In particular the approach includes identifying gaps from CER’s and residual risks (from risk management), development of a PMCF strategy taking into account considerations for products that currently bear the CE mark per MDCG 2020-6, and creating a PMCF plan per MDCG 2020-7 that is aligned with a PMCF survey. Based on a calculated sample size, the survey is deployed with subsequent data held in a compliant EDC platform with an integrated statistical package used for the data analysis and a PMCF report is created per MDCG 2020-8.


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