WebJul 16, 2024 · Article 87 Reporting of serious incidents and field safety corrective actions 1. Manufacturers of devices made available on the Union market, other than investigational devices, shall report, to the relevant competent authorities, in accordance with Articles 92(5) and (7), the following: (a) any serious incident involving devices made available on the … WebSep 27, 2024 · Safeopedia Explains Incident Report. Any incident that involves worker safety should be recorded, no matter how insignificant it may seem. An investigation of …
MDR - Article 87 - Reporting of serious incidents and field safety ...
WebOct 13, 2014 · Incident Reporting Systems Adverse Events: Reporting and Prevention By Tom Inglesby The Joint Commission and the Centers for Medicare and Medicaid Services … WebSep 1, 2024 · The validity of military hepatitis C virus (HCV) surveillance data is uncertain due to the potential for misclassification introduced when using administrative databases for surveillance purposes. The objectives of this study were to assess the validity of the surveillance case definition used by the Medical Surveillance Monthly Report (MSMR) for … cs 280cfr 説明書
Incident Reporting in Healthcare: A Complete Guide …
Webreport ( rɪˈpɔːt) n 1. an account prepared for the benefit of others, esp one that provides information obtained through investigation and published in a newspaper or broadcast 2. a statement made widely known; rumour: according to report, he is not dead. Webreport. [ re-port´] a prepared account of an event, investigation, or evaluation, usually for formal presentation to an authority or group. accident report incident report. case report a narrative in the professional literature that identifies a single incident and discusses pertinent factors related to the patient. WebJun 23, 2024 · In the context of incident reporting, information on the incident refers to the circumstances required to be reported under section 59 of the Medical Device Regulations. Malfunction or deterioration A failure of a device to perform in accordance with its intended purpose when used in accordance with the manufacturer's instructions. cs280dfl-w