What is Product Realization in ISO 13485

Valli

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#1
Dear All

We are implementing ISO 13485 and also planning to go MDD. We are into Product development of Radiology & Radiotherapy equipments. Can someone share any template for Product Plan and checklist . To my knowledge following are some of the activities to be covered. I am looking for any templates for the following stages.

1. Project(Requirements, related standards, criteria for product acceptance etc.,
2. Design Requirement Specification , containing topics like Requirement ,specificatoin , Arch, possible options, Verfication , Validation risk Management.
3. Good Project Plan for Medical Device Product development (MDD & FDA).

Thank you,
Valli
 
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Roland Cooke

#2
Re: 13485 - What is Product Realization

I would start by reviewing ISO/TR 14969.

You might also start from 'the end', work out what you will need to end up with in terms of evidence (regulatory, engineering, financial, clinical etc etc), and work backwards.


If it's all a mystery, I would really recommend getting some professional help. Probably not cheap, but cheaper (and faster) than screwing it up.
 
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