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Design and Development Plan

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Karly Chester Etzel, Sep 25, 2018.

  1. Karly Chester Etzel

    Karly Chester Etzel Member

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    Just wondering what resources people used to create their design and development plan template. We have a project charter, but my understanding is that the DDP is much more in-depth regarding details. Just wondering if anyone can point me in the right direction. I couldn't find much on ASQ, but that could be because I wasn't using the right language.

    Thanks!
     
  2. Marcelo Antunes

    Marcelo Antunes Active Member

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    Any good book on product design or engineering design will have a lot of info on design and development planning.

    I usually use as a basis Engineering Design: A Systematic Approach by Gerhard Pahl and W. Beitz and Total Design: Integrated Methods for Successful Product Engineering by Stuart Pugh as they are classics.
     
  3. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day
    @karly Chester; May I inquire as to why you wish to create a "...plan template"?
     
  4. Karly Chester Etzel

    Karly Chester Etzel Member

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    It's one of our DHF requirements and we want to have a minimum of information required. We have a project charter that's reasonably comprehensive. I'm just looking for what information I'm maybe missing on the project charter that we would need for a DDP.

    thanks!
     
  5. Karly Chester Etzel

    Karly Chester Etzel Member

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    Thank you for your reply. I will have to consult the engineering department to see if they have any similar resources.
     

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