Materiovigilance is the coordinated system of identification, collection, reporting, and
analysis of any untoward occurrences associated with the use of medical devices and …

Assessing the value of health technologies, through health technology assessment is
critically dependent on the existence of relevant and robust clinical data on the efficacy …

Background and purpose Joint Replacement Registries play a significant role in monitoring
arthroplasty outcomes by publishing data on survivorship of individual prostheses or …

Highlights•We describe our experiences in publishing European Public Assessment Reports
(EPARs) and Australian Public Assessment Reports (AusPARs).•EPAR and AusPAR …

Medical device regulatory standards are increasingly incorporating computational modelling
and simulation to accommodate advanced manufacturing technology and demand for …

Background Previous safety issues involving medical devices have stressed the need for
better safety signal detection. Various European Union (EU) national competent authorities …

Background Unsafe and dangerous medical devices have entered the European market
during the last decade, raising public awareness. Consequently, regulatory processes and …

The medical devices may have caused serious events for patients and could have
contributed to healthcare costs. The post-market surveillance, as part of Medical Device …

Introduction Post-market surveillance of medical devices relies on compulsory and voluntary
reports. Although direct consumer reporting of medical device-related adverse events (AEs) …

Materiovigilance is regulatory system to study and follow incidents that might result from
using medical devices. To trail the occurrence of untoward effects associated with medical …