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Design Change/ECO Related Question

#1
Hi all,
Not sure if I'm in the right place as this is new to me. But I have a medical device that my company made with two specific functions initially and we have since designed another feature which involves adding another attachment to the original device. Where could I find the necessary steps we need to take to ensure that the necessary guidelines are followed when performing either a design change doc or ECO doc? Any and all help if greatly appreciated, and if you need more detail please let me know.
 
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#2
If you are adding new features and an attachment, this is certainly a design change. Your own QMS procedures must ensure that impacted Design History File documents like Design Inputs, Design Outputs, Design V & V, Design Transfer, and your Risk Mgmt File are maintained during the change control process. Be certain to include a Regulatory Assessment to see if your new / enhanced product triggers new approvals in the markets you sell your product. Your project plan may have already covered this. If you are handling this as a change, create a Design Change Plan to assess impact on each of the listed documents and update the documents accordingly.

Going forward, I encourage your firm to explicitly define what is a design change and the process to complete it. Generally, f a DHF document is impacted, with the exception of inspection procedures, that would trigger design change process.

One more. You may want to search the Cove on this topic. Design Change seems to come up periodically and seeing how others have answered this may be helpful. Good luck.
 
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