Risk-Based Postmarket Surveillance (PMS) In The Age Of EU MDR A Systems Approach
Risk-Based Postmarket Surveillance (PMS) In The Age Of EU MDR: A Systems Approach 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 b...
Source: meddeviceonline.com
