Learning Outcomes of this lecture.
Understand EU 2017/745(MDR) & EU 2017/746 (IVDR).
Timelines for the new regulation.
Differences between the regulation and the directive.
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MDR & IVDR
Теги
Regulatory affairsMDR 2017 745Medical devicesmedical device regulationEuropean Union Medical device regulationISO 13485Process ValidationISO 14971Risk managementEURLEUDAMEDCompetent AuthorityOperations managementNotified Bodyin vitro diagnostic medical devicesIVDR 2017 746UDIIVDD 98/79/ECMartin Conneelyquality management systemMDD 93/42/EECAIMDD 90/385/EECQuality AssuranceQuality Control
