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The first article in this series examined 5 common misconceptions in data integrity (DI). In this article, the author now shares 9 example areas...
January 15, 2021 HURON, SD – Huron Regional Medical Center (HRMC) honored employees for 740 years of combined service in addition to two employees for exceptional customer service skills at the hospital’s Employee Awards Presentation on Friday, January 8, 2021, at the Legacy Plaza Auditorium. During the event, which was hosted at the hospital and online to accommodate social distancing, 38 employees from 19 departments were recognized for sharing their hearts and years of service, ranging from 5 to 40 years, with hospital patients. Employees in attendance enjoyed a meal while reflecti...
. 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 ...
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...
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...