Thanks for the reply. I have that document and I also use ISO 23640:2011 In vitro diagnostic medical devices: Evaluation of stability. Do you now where FDA or EU mentions that is required?
I think the best standard for the US is the CLSI EP25a as QAengineer said. In any case, the relationship between the CLSI and the European Harmonized standards is acceptable.
Thanks for the reply. I have that document and I also use ISO 23640:2011 In vitro diagnostic medical devices: Evaluation of stability. Do you now where FDA or EU mentions that is required?
Its an implied requirement from the FDA /EU or any regulatory agency because the Requirement for PERFORMANCE OF SAFE & EFFECTIVE medical device/IVD is part of the essential requirements, so I would say the stability is one of the key requirements that could be used to strengthen your performance claims of the marketed device.
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