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ISO 13485 & EU MDR - Expert Advice Community

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  • Customer feedback

    Our product is a class III single-use sterile device. We don't have any customer property and therefore Customer property, Installation, and Service have been excluded (not applicable). Does customer complaint/ feedback consider as Customer property?

  • Medical Device File

    I just start to work on document and record control. I cannot find "Medical Device File" in the tool kit. Could you provide me some guidelines/examples?

  • Quality management

    Does any ISO 9001, 13485, etc require a company to have a Quality manager? I know ISO 17025 and ISO 34 did.
  • Expired calibration of infusion/drivers

    I'm looking for information on expired calibration of infusion/drivers. If an infusion/driver had a service/calibration sticker stating should not be used after April 2019 and was being used in an intensive care unit to keep a person alive would this breach the regs or SOP

  • ISO 13485 vs. ISO 9001

    I would like to know what are the similarities and differences between the two standards. I have experience with ISO 9001 and I have to implement ISO 13485. Could I rely to ISO 9001 or I need to get acquainted with this standard in detail?

  • ISO13485 and MDSAP

    Does your toolkit support requirements of ISO13485 in the scope of MDSAP?

  • Updating documentation

    Hello, my company has medical device software and we have a lot of documents for our technical file. We updated a few documents from version 2 to version 2.1, new information was added, but a lot of documents don't have any changes (etc. we updated Clinical evaluation file, but we didn't changed System Architecture file). So my question is, should we update ALL technical file documents to V2.1, o should we change documents, which had changes - to v2.1 and other TF documents, which has no changes - leave v2.0? Thank you!
  • Mandatory documents

    !Quick question: certain of the documents do not appear to apply to me but they are marked as mandatory – for example, #12 re: sterilization. Of course, as a software company, I am not involved in any such activity, so I presume it is mandatory for audit if you are involved in sterilizing MDs? Or is it that I need to have such a document in my company repertoire, even if I don’t use it (to meet the standard)?!

  • ISO 13485 certification

    My question is for a company working on user-friendly comprehensive software that can help hospitals or doctors to record all medical data. If they plan to go for ISO 13485 implementation, is it must for all employees to be trained on ISO 13485 and the hired QA person for this role is requires any special qualification other than ISO 13485.

  • Evidence for Product realization

    We do not manufacturer medical devices/equipment, but we do service and repair them. We are looking to get ISO13485 certified as this will help with being compliant hopefully to the new MDR coming out in May 2020. Section 7 of ISO13485 is product realization. As we do not manufacturer but service, do we still need to provide evidence for this section?

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