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Risk-Based Postmarket Surveillance (PMS) In The Age Of EU MDR: The Binding Thread Of Risk Management
By Jayet Moon, author of the book
As the central focus of the EU’s Medical Device Regulations (MDR), postmarket surveillance (PMS) and its related processes and subsystems have been in the limelight since 2017. This four-part series, using a fresh perspective, takes a bottom-up approach to PMS and starts by elaborating on the state of the art on the incident investigations in Part 1
. “Investigations” are the basic iota of the PMS system upon which all further analysis, synthesis, and decision-making is based. With clarity on this most fundamental unit of PMS, ....

Drexel University , United States , United Kingdom , Veronica Cavendish Stephens , Angelina Hakim , Karun Mathew , Risk Management Society , European Union , Management Institute , World Health Organization , Texas Tech University , Abbvie Inc , Jayet Moon , Equality Risk , Device Regulations , Occurrence Rate Of Malfunction , Frequency Of Harm , Key Risk Indicator , Failure Modes And , Associate Director , Quality Risk Management , Project Management Institute , Certified Risk Management Professional , Chartered Quality Professional , Enterprise Risk Management Certified Professional , ட்ரெக்செல் பல்கலைக்கழகம் ,