Hello Priya, There is no guidance on the time interval to update the Plant Master File (PMF). Since this document is included along with the Quality Manual requirements, it needs to stay current. This means the change management should take care ...
Saschka, There has definitely been some great discussion especially regarding reprocessing/useful life. Here are a few resources I like to keep handy: https://compliancenavigator.bsigroup.com/en/medicaldeviceblog/sterilization-of-medical-devices2/ ...
Anne, For the UK: For Devices: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1137842/Device_Registration_Reference_Guide_Feb_2023_Final_v1.pdf For Medicines I find the pre-submission checklist ...
Hi Team, Hope everyone doing well I want to be the part of the RA community, so can you please add accept me as the part of the group What's app no :- 9730535072 G mail:- gahinep@gmail.com Regards Pritesh Gahine
Please add Yogita Khare 7045039568 Thank you, Yogita
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