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

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.

There are quite a few existing discussion threads on Product Realization (http://Elsmar.com/Forums/search.php?do=process&titleonly=1&query=product+realization).

Here is a more comprehensive list of Product Realization (http://www.google.com/custom?domains=Elsmar.com&q=product+realization&sa=Search&sitesearch=Elsmar.com&client=pub-1385417534940691&forid=1&channel=6124086287&ie=ISO-8859-1&oe=ISO-8859-1&cof=GALT%3A%23008000%3BGL%3A1%3BDIV%3A%23336699%3BVLC%3A663399%3BAH%3Acenter%3BBGC%3AFFFFFF%3BLBGC%3A000099%3BALC%3A000000%3BLC%3A000000%3BT%3A0000FF%3BGFNT%3A0000FF%3BGIMP%3A0000FF%3BLH%3A50%3BLW%3A350%3BL%3Ahttp%3A%2F%2Felsmar.com%2Fpng%2Fheader-G-search.png%3BS%3Ahttp%3A%2F%2FElsmar.com%2FForums%2F%3BFORID%3A1%3B&hl=en) discussion threads.

I'm not sure how many templates there are that you are looking for, but here a few Product Realization templates (http://elsmar.com/Forums/fileslist.php?mode=allfiles&sortby=filename&pageamt=2&criteria=realization).

This is a good post on Risk Management (http://elsmar.com/Forums/showpost.php?p=160812&postcount=4)in relation to Product Realization found in this thread: Planning of Product Realization - Risk Management - ISO 13485 Clause 7.1 (http://elsmar.com/Forums/showthread.php?t=14479)

Hi Valli,

Great advise from Roland, Marc and Harry - work on these and if you still have questions, pl come back to the Cove :)

Thank you everyone. Will go through.

Regards,
Valli