Transcription of Effective post-market surveillance
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Effective post-market surveillanceUnderstanding and conducting vigilance and post-market clinical follow-upIbim Tariah, technical Expert, BSI AmericasRebecca Pine, Medical Devices Consultant2 Effective post-market surveillance BSI BSI/UK/440/ST/0614/en/HLIntroductionIn order to comply with the European Union (EU) Medical Device Directives 90/385/EEC Active Implantable Medical Directives (AIMD), 93/42/EEC Medical Device Directive (MDD) and 98/79/EC In Vitro Diagnostics Device Directive (IVDD) (referred to as The directives hereafter), manufacturers must conduct post-market surveillance (PMS). As outlined in the quality assurance area of the annexes of these directives, PMS requires: 1.
It is important to note that the requirements ... vigilance, post-market clinical planning and data as a critical part of the design dossier and/or technical documentation of a device. Two processes which warrant specific focus are the ‘reactive’ vigilance process and ... (NBs). The latest revision of the vigilance guidance document is ...
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