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Design Control Documents

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Guest user Created:   Mar 08, 2019 Last commented:   Mar 08, 2019

Design Control Documents

Our previous attempts at drawing up design control documents were met with criticism from the auditor. Would you be able to email me an example of an approved design control document for ISO13485:2016. We need to improve the format too so a template would be great if you have one. I need help defining the user requirements, inputs, and outputs.
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Verlene Law Mar 08, 2019

Answer:

For the design control document, we do have one available on hand: https://advisera.com/13485academy/documentation/procedure-for-design-and-development-iso-13485-2016/ .

Concerning the user requirements, you should think about the roles of each function in the company with respect to design and development. Some examples of inputs could be intended application, usability requirements, risk control and etc. For outputs, you should factor in raw materials, manufacturing processes and quality assurance.

For more information, please refer to:
-How to manage design and development o f medical devices according to ISO 13485:2016: https://advisera.com/13485academy/blog/2017/08/24/how-to-manage-design-and-development-of-medical-devices-according-to-iso-134852016/
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Mar 08, 2019

Mar 08, 2019

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