Risk-Based Postmarket Surveillance (PMS) In The Age Of EU MDR Risk-Based Trending
. Successful implementation of an effective EU MDR-compliant PMS requires a systems approach which requires appreciation of not only the organizational context within which PMS operates but also the knowledge management as it relates to PMS generated data, information, knowledge, and wisdom. . It not only explores the interfaces between risk management and PMS but also discusses the postmarket aspects of risk surveillance and their accomplishments. Part 4 details an important upcoming topic with relevance going beyond EU MDR. Risk-based incident trending for postmarket signal detection is ...
Source: meddeviceonline.com