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  • Is ISO 9001 mandatory for company distributing medical devices?

    Is ISO 9001 mandatory for company distributing medical devices?
  • Implementation questions

    My company has manufactured a silicone prosthetic liner. My questions: 1. Do I need to perform mechanical tests on the liner? If so, which organization can do this? 2. How long do I need to do clinical trials on the liner? How many months and how many patients need to wear the liner as part of the clinical trials?
  • Regarding intended purpose or intended use

    We had a sit down with one of our regulatory consultants and went through our new Manual/IFU ( it’s a combination in one document) and when we came to the chapter about intended use, she proclaimed that since the 26 of may- and MDr is in full place. Its not called Intended use anymore and everywhere it is stated intended use must be replaced with intended purpose instead- is this really the case? Then a lot of the documentation from Advisera that we purchased in December is outdated? Can you confirm or deny this?
  • Question about data storage

    I am following some courses on medical devices'ISOs on Advisera and I have been given this email to ask a particular question. I was wondering about the storage of data during lab experiments prior FDA/CE mark. We record everything on an electronic lab journal (protocol, procedures and conclusions) but I was wondering whether the raw date should also be embedded into the eLN or it is enough to refer to the documents containing data (sometimes big data) in order to be FDA/CE compliant. Thank you very much in advance
  • Expanding and elaborating scope

    My question is 1- I am going to Update the medical device file as per Eumdr (Article 1) so what should be the scope? As per my understanding, I have defined the scope for PACS This procedure applies to: Technical/engineering documentation required for the release of XYZ medical device software. Changes to the product, process, facility, quality system, or organization. All countries and territories where XYZ medical devices are approved for sale (EU for CE Marking) Just want to confirm is this sufficient scope or should expand our scope or if you suggest some more. 2- What is the new changes as per new ISO 15223-1:2021 for PACS software 3- Is there any specific retention time period for software? As per MDR 10 years after the last device covered by EU DOC & for implantable for 15 years.
  • Lateral flow device

    i am trying to find out what a lateral flow device using saliva would come under with the FDA class 1 or class 2
  • Calling organization's products after certified ISO 13485 QMS in place

    With a certified ISO 13485 QMS in place  which is in alignment to national regulatory body as well (though not audited by national regulatory body), can an organization call its products:
    1. GMP grade products or
    2. ISO13485 conforming products or
    3. ISO 13485 and GMP conforming products
    Note: I have not used the word compliant for GMP since as I understand that the organization needs to be audited by regulatory body to claim the same?
  • Risk Management and FMEA

    I am working on completion of our Risk Management Procedures. Is FMEA required for Class I devices, or is there a simpler alternative we can use?  
  • Examples of Applicable regulatory requirements

    What are examples of Applicable regulatory requirements?
  • Does ISO 13485 cover code required electrical and fire approval such as UL?

    Does ISO 13485 cover code required electrical and fire approval such as UL or is this just medical approval?
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