Development of Medical Software for 510(k) - Where to start

M

meddi

#1
Dear all,

It is great that I found this forum. I am posting for the first time and I am not experienced. My question is very vague because I do not manage to pose it more precisely yet. Maybe you can give me some tips.

We are creating with 3 colleagues a company to commercialize medical software for image-based diagnosis. The main market of our application is the US, and getting 510(k) is our top priority.

We know well how we want the application to be and have the technical knowledge to develop it. However, we have no experience with certification issues. We would have maximum ~10 k$ for certification-related consulting (if absolutely needed, since we have no external funding). But we have our own time and much motivation available.

I have seen the useful replies to KAMay at thread 39302 (cannot include link here because it is my first post) but without experience I find it difficult to know where to start.

I see many options but maybe none of them is correct or we have to do all in parallel:
*read the FDA's Principles of Software validation several times until understanding how to establish a development process which fits with it
*buy IEC 62304 and study it
*buy and look into ISO 9001, ISO 13485, ISO 14971, IEC/TR 80002-1
*get a consultant since the first day and ask him for help and templates (then our budget might be gone since the beginning)

Based on your experience, what should we do and in which order?

I guess that most people here work in a company with a complete infrastructure and a large budget only for this purpose, so my questions might sound very naive. Still, I would be grateful for any tips. If you think that we have no chance of getting 510(k) without investing much more money (besides our own time), this would be also an important piece of information. :frust:

Thanks! meddi
 
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sagai

Quite Involved in Discussions
#2
Welcome,

first I would suggest to listen and watch courses from CDRH Learn:
http://www.fda.gov/Training/CDRHLearn/ucm162015.htm

It cost only the time you spend on it.

Read the followings:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820 21CFR820
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=807
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=801

--
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070627.htm
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085281.htm
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073778.htm
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077812.htm
http://www.fda.gov/RegulatoryInformation/Guidances/ucm125067.htm
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm212795.htm
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089543.htm
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm074973.htm
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077274.htm

Get these standards:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?id=22436
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?id=26639
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?id=19639

When you finished (or feel hopeless), come back to the Cove and ask us :)

This is a low budget version of how to start in this arena :)

br
Sz.
 
M

meddi

#3
This is great! Thank you. I did not know about the CDRH Learn Courses & videos.

For the standards, are there places to get them other than the official ISO website with associated fees?

I think I have enough work for a few days with the FDA content :)
 

sagai

Quite Involved in Discussions
#4
In case you dedicate your next couple of years for sw development in the medical device area, I would suggest to buy them. They are great, gives real assistance for the understandings, but I would suggest to have them after you have finished with the FDA materials and they are almost clear.
You can not have a copy, they are copyrighted and even the electronic copy has watermarks for future identification.
When it will be important, someone may have an idea from where to have it on a lowest possible price.
br
Sz.
 
M

meddi

#5
ok, thanks. I will start with the FDA materials in any case. The relevant ISO standards are together below thousand $: if, following your low budget strategy, this was our only cost, we would be fine :)
 
M

meddi

#6
By the way sagai, is the picture beside your posts a real picture from you?
From the content, I don't feel like getting tips from an insane person (rather the opposite), but watching the picture I would start hesitating ;)
 

sagai

Quite Involved in Discussions
#7
I don't feel like getting tips from an insane person
after a couple of years in this industry, i am happy to survive only with this handicap, the hat helps me to survive :lmao:
send us a picture of you after your first audit :notme:

seeeriously :cool:

Have some more news, establishment registration and listing is not free of charge, 2 see more.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm
http://www.fda.gov/MedicalDevices/D...YourDevice/RegistrationandListing/default.htm
http://www.fda.gov/MedicalDevices/D...urDevice/RegistrationandListing/ucm053165.htm


:tg:
Sz,
 
M

meddi

#8
:lol: you are right, I start going crazy just by seeing the amount of documents which need to be read. It is insane! Maybe in a few months I ask you at which shop you bought the hat to get the same one...
 
E

esalsan

#9
As a very general overview of the process, EMERGO group (I have no relationship with them or association of any kind) have regulatory overviews, including a very simple flowchart for the USA. In addition to that, the World Health Organization published a worldwide overview of medical device regulations that you will find educational.

Standards are a good guidance and will provide you with guidance, but I would start directly with the regulations: 21 CFR 820. Documents like the QSR (Quality System Regulation) manual and the QSIT (Quality System Inspection Technique) guide will also help you to interpret the requirements.

There are many guidance documents that would be applicable to you. From the top of my head, the ones that would be more relevanto to you are:
- Principles of Software Validation
- Off-The-Shelf use in medical devices
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
(I'm sure Sagai has already provide you with links to those).

Regarding the thoughful list of standards you mention:
ISO 9001 are general quality system requirements;
ISO 13485 are specific quality system requirements for medical device manufacturers;
ISO 14971 talks about risk management for medical devices;
You'll find references to ISO 13485 in ISO 14971 and vice versa.
IEC 62304 requires the implementation of risk management in accordance ISO 14971, and contains references to ISO 13485.

You should bear in mind what the classification of your device is, as this would significantly change the approach to follow. For instance, diagnostic devices are Class III (maximum risk) and they require Premarket Approval (PMA) instead of 510(k).

Enjoy your reading stage!
 
R

rclanzillotto

#10
The focus is the 510K so forget ISO 9000 and 13485 for now. They are not required. I do recommend the 62304 standard which is an FDA consensus standard. You'll need software requirements and specification documents as well as VnV reports the extent of which is based on the class of products. I do recommend you use a consultant for templates and guidance. Good luck. Rich
 
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