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  • ISO 13485 implementation

    When a company is going for IS 13485 certification, is it mandatory to go for ISO 9001

  • What to exclude from Procedures and/or Quality Manual?

    We will be NOT be designing or making medical devices. We will be molding plastic components that do not require sterilization. What should we exclude from our Procedures and/or Quality Manual?

  • ISO 13485, clause 4.2.3 Medical Device File

    Does a service company who is only transporting medical devices from point a to point b, have to have a Medical Device File, ISO 13485, clause 4.2.3? I won't think so. Isn't this not applicable since they are only transporting goods from point A to point B.

  • 13485 arrangements for Proof of Concept work

    We have a couple of medical device products already registered with the MHRA and submitted to FDA 510K Approval but are now getting into medical device proof of concept mini projects and I want to minimize documentation requirements as these projects are short term and do not become devices. Our current medical device project paperwork is too cumbersome for these and I wonder if there are minimum requirements laid out by the standard.

  • 21 CFR 820 / ISO 13875

    We are registering with the US FDA. I have determined if I get compliant with ISO 13875 I can pretty much meet the requirements of 21 CFR 820. It appears your company is not based in the US. I would like to use it to build our QMS. At some point, we will be attempting to bet ISO 13875 certified but at this point it is not required. Please advise. Thank you.

  • CE Marking and Major NCRs

    If a CE marked product gets a major NCR from a notified body, does that mean you have to cease selling it until the NCR is addressed?

    I am just trying to understand if selling a CE approved product is legal or illegal to sell with known major NCRs against it?

  • List of certifying bodies for ISO 13485

    Thanks for the kind Webinar. Can you please suggest any certifying body for ISO 13485 in Germany?

  • Certification of QMS

    Thank you for the webinar, it was useful.
    But I would like to consult a bit more….Could I?

    This is regarding certified QMS according to ISO 13485.

    MDR does not have indication that QMS must to be certified, there is indicated minimal requirements for  QMS. Isn’t it enough?

    In *** we have accredited notify body, and they told that there is no information or indications about certified QMS, we are new to this field, and as I understood form your webinar this is new changes, and that there still misunderstandings possible.

    If you would be able to advice me I would be really grateful.

  • Need for ISO 13485 certification for PRRC

    I want to offer my service as PRRC, related to the MDR. Do I need (would it be useful) to have ISO 13485 Certification?

  • Internal audit schedule

    I am working on a new internal audit schedule, now I was advised to start a 3 year cycle, auditing the most important processes first.

    Nice, for me all processes feel important. There certainly is an kind of standard perception on the importance of processes / ISO13485 paragraphs.

    Are you able to help out and guide me in this one?
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