Learning Objectives
Understand what is meant by operational qualification.
Understand during the OQ phase, all the items in the test plan are tested individually and their performance documented.
Understand that other periphery items are also developed during this stage
For more detail on Process validation: [ Ссылка ]
An example of an operational qualification
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
