Open AccessVigilance System Requirements Across US and EU for Medical Device
Author(s) -
N Shashank,
M. P. Venkatesh,
Yamini Krishna,
Teerath Kumar
Publication year - 2020
Publication title -
international journal of pharmaceutical quality assurance
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.114
H-Index - 7
ISSN - 0975-9506
DOI - 10.25258/ijpqa.11.3.21
Subject(s) - vigilance (psychology) , business , risk analysis (engineering) , member states , patient safety , medical device , medical emergency , occupational safety and health , computer security , european union , medicine , computer science , health care , psychology , political science , law , neuroscience , biomedical engineering , economic policy , pathology
Medical device vigilance is concerned about device problems (incidents) their analysis and mitigation to ensure that device performance is good and that patient safety are maintained. The main aim of this is to outline the criteria of the medical device vigilance program and to highlight the requirements that still remain in the state laws of regulated markets (US and EU) and to increase access to safe, reliable and therapeutic benefits. The severity of the Subject, risk assessment should carried out by the manufacturer prior to marketing. In US, Medical Device surveillance deals with post-marketing monitoring where the manufacturer or importer is required submit reports to regulatory authorities; same as in the EU. US medical device tracking system involved with different sections to update adverse event. The user or manufacturer has to report incidents to member states where necessary actions are to be taken as early as possible to protect or reduce hazard of casualty or severe decline in terms of safety and quality by implementing the CAPA for risk analysis.