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Unanswered posts

  • This message was posted by a user wishing to remain anonymous Hello community! Does your regulatory affair department review all the documents that are going to be part of a Third Party Dossier? I mean, acting as a CMO some of your clients may have ...

  • RAPS is looking for a number of subject-matter experts to help us develop and update online courses in regulatory affairs. See our opportunities here! ------------------------------ Ryan Connors Social Media and Communications Specialist RAPS - ...

  • Hello everyone, Can you please suggest to me any third-party names who performed the medical device cybersecurity assessment especially as per FDA guidance? Thank you in advance ------------------------------ Shalini Yadav Sr. Regulatory affairs ...

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    FDA pre-IND meeting

    This message was posted by a user wishing to remain anonymous Hi all, I am working on a project with a client who wishes to consult FDA on his development protocol. The client has put together a synopsis for his study however they have included two ...

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    ECG device applied parts

    This message was posted by a user wishing to remain anonymous Hi all, My question is: are all ECG devices automatically classified as CF applied part according to IEC 60601-1 and IEC 60601-2-25 or can they be BF, as well? What confuses me a bit ...

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