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  1. CharleyBarks

    Using Summary Sheet for Documenting Training Activities

    Hi all, Our company develops software for the medical device manufacturers. We are certified against ISO 9001 and ISO 13485. This year we were audited by our certification body and received several recommendations. One of these recommendations makes me confused. It is related to training...
  2. CharleyBarks

    Control of the Development and Test Environment

    Hi, I‘m working for IT company. We produce the software for medical devices. I’m trying to find out which clause of ISO 13485 covers control of the development and test environment that we establish during software product development and testing. Is it p. 6.4 Work Environment or some of the...

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