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  • 1.  Design Input Requirements & Standard Gap Assessments

    This message was posted by a user wishing to remain anonymous
    Posted 16-Jun-2023 07:37
    This message was posted by a user wishing to remain anonymous

    I am interested in knowing how others manage design input requirements and standard gap assessments. I'm from the school of thought that the design input requirement is somewhat at a macro level and the standard gaps assessment is a follow-up activity to determine which clauses are applicable to your device which in turn drives the design output, while others believe you need the gap assessment to establish the design inputs.

    Design input => compliance to IEC 60601-1

    Complete the gaps assessment – identify the applicable clauses.

    Establish/create your design outputs.

    Appreciate any input you can give.



  • 2.  RE: Design Input Requirements & Standard Gap Assessments

    Posted 16-Jun-2023 07:39

    The design input requirements are defined based on the intended use, user needs, regulatory requirements, and other high-level considerations. The focus is on capturing the overall objectives and functional requirements of the device without delving into specific standards or regulatory clauses. Once the design input requirements are established, a standard gap assessment is performed to identify which clauses or requirements from relevant standards, such as IEC 60601-1, are applicable to the device. This assessment helps determine the extent to which the device needs to comply with specific clauses of the standard, and it influences the subsequent design output activities.



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    Raje Devanathan
    Amerisource Bergen
    TPIreg, Innomar Strategies
    Senior Manager - Regulatory Affairs, Medical Devices
    rdevanathan@tpireg.com
    3470 Superior Court
    Oakville ON L6L0C4
    Canada
    ------------------------------

    Original Message


  • 3.  RE: Design Input Requirements & Standard Gap Assessments

    Posted 16-Jun-2023 08:19

    Hello anonymous

    Rajeswari provides a valuable insight here. The term "gap assessment" can be interpreted in many different ways. What kind of gap assessment are you referring to?

    To add to Rajeswari's comment, we should also consider the output of risk management activities, especially characteristics related to safety and reasonably foreseeable misuse, before finalizing our design inputs. This is a common gap in the current industry practice.



    ------------------------------
    Naveen Agarwal, Ph.D.
    Problem Solver | Knowledge Sharer.
    Let's Talk Risk!
    @https://naveenagarwalphd.substack.com/
    ------------------------------

    Original Message


  • 4.  RE: Design Input Requirements & Standard Gap Assessments

    This message was posted by a user wishing to remain anonymous
    Posted 16-Jun-2023 13:44
    This message was posted by a user wishing to remain anonymous

    Doesn't really matter what you call it, as long as it gets done. Document what you think the thing must do and then show that it actually does.


    Original Message


  • 5.  RE: Design Input Requirements & Standard Gap Assessments

    Posted 17-Jun-2023 08:20

    Design-development inputs are defined in ISO 13485:2016 7.3.3 and include as@Naveen Agarwal indicated Safety Requirements, but also "functional, performance, usability as well as regulatory requirements and standards, outputs of risk management, information from previous similar designs, and other requirements essential for design and development of the product and processes".

    You can get more information on these requirements at "a practical guide ISO 13485:2016 Medical devices Advice from ISO/TC 210".  It is an official ISO Handbook available from your standards provider. 



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    Edwin Bills
    Edwin Bills Consultant
    ASQ Fellow CQE, CQA, CQM/OE, RAPS RAC
    elb@edwinbillsconsultant.com
    ------------------------------

    Original Message


  • 6.  RE: Design Input Requirements & Standard Gap Assessments

    Posted 17-Jun-2023 13:03

    It would also be interesting to note the clinical evaluations and inputs required to proceed with any design input changes even if risk management file is updated and intended use is established. As a student I would love to learn more about this topic from more clinical insight perspective which should cover customer needs. 

    Thankyou  



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    Sukanya Madan Mohan
    Regulatory affairs student
    Brampton ON
    Canada
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    Original Message


  • 7.  RE: Design Input Requirements & Standard Gap Assessments

    Posted 18-Jun-2023 16:29

    The prior responses illustrate design inputs arise from a wide variety of sources.  Standards and regulations are typically stated in broad terms applicable to a wide range of products and applications. When citing standards and regulations, I advise against citing them in general terms.  Rather, designers should cite specific applicable clauses and include terms (criteria) that can be verified by measurement, testing, or inspection. 



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    Wayne Schrier
    [Coastside Biotech Consultants]
    [Principle Consultant and Owner]
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    Original Message


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