ISO 13485 & EU MDR - Expert Advice Community

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  • Transition to ISO 13485:2016

    We have an assessment of our QMS to 13485-2003 and need to be in line with 13485-2016 what is the best way to accomplish this?

  • Effectiveness of QMS and Product Recall

    1. How can you measure the effectiveness of QMS? 2. Do every product recall will require an advisory notice? Is there any advisory notice which will not required a product recall?
  • 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)?!

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