MDD, Technical File, Clinical Evaluation for PACS/DICOM Viewer

F

Fulcrum

#1
Have 510K, small company, I am it on regulatory front, and I am more clinician than regulatory expert. Pursuing 13485 with SGS as NB, EU, Canada, Australia are targets. Product is all software, analog to PACS/DICOM viewer, class IIa (or IIb, depending on auditor).

Not sure how to write up clinical evaluation for technical file with a technology like ours (i.e. no clinical trials needed, a lot of papers on the benefits of radiographs, CT, PET, etc., but hard to justify our particular product without feeling like I am just asserting predicates). Have a consultant who has worked very hard on this, began with Roentgen, carried it through to DICOM, etc.

So, I have a lot of papers and a great deal of writing, but hate to submit it as it doesnt make sense to me that this information is useful vis a vis clinical evaluation of something that is more enhancement of an established tool than advancement of the science/field...and I hate to do things that dont make sense as it contributes to a schism between development and QA.

So, my question is what should one do vis a vis clinical evaluation of an established product offering like viewing and storing DICOM? For example, would I need to repeat clinical evaluations for a PACS? Or can I just say that I have a new PACS and rely on the auditor understanding?

Any examples of what has been done for PACS or DICOM viewers appreciated, though not expected.

Apologies if there are existing threads that have answered, appreciate the help.

Best Regards,

s
 
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medwise

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#2
Hi Fulcrum,

As you mentioned that Australia is one of your target market, I would like to advise you that TGA has their own set of requirements for clinical evidence. However, you may not even need to take that path of getting access to Australia. I know this may sound a bit contradictory but this is how it is :D.

As you have said that your organisation is small, I'm assuming that you do not have an office in Australia. So the way out for you is to get CE mark in EU and then an Australian Sponsor (maybe an Australian Distributor or Service Providers) and get the registration.

In terms of clinical evidence, you may seek services of regulatory consultants who specialise in this area. From the information you have provided that you have a lot of papers, Literature review is the way to go for you. Do not panic every problem has a solution.

Kind regards
Romit:tg:
 
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