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clinical evaluation

Discussion in 'EU Medical Device Regulations' started by riri1912, Feb 6, 2018.

  1. riri1912

    riri1912 New Member

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    Hi
    I'm a trainee in regulatiuon and quality management system. I'm asked to do the clinical evaluation of a medical device
    Does any one have a template of : - a clinical investigation procedure
    - a clinical evaluation and post market clinical follow up procedure
    thank you
     
  2. Ethan - CiteMed.io

    Ethan - CiteMed.io New Member

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    We have a ton of free materials on our blog that might be helpful (but no CER template offered freely).

    I'd also check out 'Open Regulatory' for some decent open sourced templates for MDR.

    Best of luck!
     
    Last edited by a moderator: Jun 12, 2024