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  • Document control version question

    I am hoping that someone can help me with a question about document control for ISO 13485. With version control you give examples in the documentation as per below: https://i.imgur.com/zn36OTF.png

    With regards to the versions above, there is a document on version 1.2 and another on 0.6. When changes are made how are you suggesting document version is changed? Does it go from 0.0 to 0.9 and then go to 1.0? Or are minor changes illustrated by the .X number and major changes be a whole numerical shift from 0 to 1? The procedure doesn’t explain this hence me checking. And if it is the latter, how should I distinguish between a minor change and a major change?

  • 13485 Implementation

    My background in 13485 was within a manufacturing company that produced medical devices. I have now been tasked with implementing a 13485 QMS where there is no physical product. The offering facilities and services but no commercialised product. How would I tailor the 13485 standard to a facility and service when it is very strongly worded towards having a product?

  • New EU MDR - Technical File new document format

    Hello, I am working on the TF of a Class IIb device new document format to be compliant to new EU MDR regulations. I am at section Product and Design Specifications - USER REQUIREMENTS. My question is: what do they mean by User Requirements? the question is not specific enough. thank you for your quick response. Taly Bendayan

  • Acceptable or Not Acceptable

    hello quick question, Acceptable or Not Acceptable When taping an entry in a lab notebook, Is hash marks (") acceptable on the taped entry. I'm used to name and date, but I am at a new company and they use (")

  • CE Marking

    Hello, I was hoping someone could advise me on an issue with CE from a complaince perspective. A manufacturer I use has a valid CE certificate until the end of June 2022, they have told me the renewal is going thorugh, but due to new laws it is more complicated and they may not be able to obtai the renewal until the end of July. But they are sure there will be no issue. I have two questions: 1 - Bewtween the end of June and when they get the renewal, can I sell the products I hold that were manufactured under a valid CE, even though it will be out of date? 2 - If I purchase new products that have been produced without a valid CE, they will not be compliant will they? Thank you  

  • Production Part Approval Process

    I am working for a Medical Devices Company already certified to ISO 13485. Where does (PPAP) Production Part Approval Process fit in please?

  • Single Registration Number for MDR

    What is considered a Single Registration Number for MDR? How do you acquire it? I have a UDI for each product and Device Nomenclature Codes(GMDN)

  • Design and Development Agreement

    Do you have a template for "Design and Development Agreement". I mean for outsourced process?

  • Design and Development Agreement

    Do you have a template for "Design and Development Agreement". I mean for outsourced process?

  • Gaps From MDR to CFR

    What are the Gaps From MDR (SaMD) to also comply with US FDA regulations CFR (21)?
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