IEC 62304:2006: Medical device software SDLC- CE Vs. Fda 510(k) submission

Hello Folks,
I am new to these standards and hope that you can patiently answer some of my silly questions.

We are very small company that develops Radiology Imaging PACS systems. We are categorized as PACS device (892.2050 LLZ) under title 21 CFR part 820. The DICOM PACS and DICOM VIEWER are catergorized as CLASS II with Moderate Level of Concern device.

This is a completely software based Class II medical device.

We are interested in getting USA-FDA and Europe CE approved so that the device can be recognized in both continents.

My question is what would be the best approach to perform the complete SDLC process that can adhere to both the FDA and CE standards.

I looked into the ISO/EN IEC 62304:2006 as well the documentations related to FDA 510(k) submission standards. But what would be best route that would incorporate and be acceptable/compatible to both standards?

Are there any Test plan templates that I can use for Test Validation and Verification?
What are the steps involved in the IE 62304 and FDA 510(K) that are similar and what steps are not?

My goal is to certify with both standards and find processes that compliment both FDA 510(k) and CE (IEC 62304:2006).

Please need your guidance and help. Are there any templates that I can use for each step of the process from Research & Analysis to Deisgn and testing etc?

Thank you for hearing me out.

Best regards
Tim

Can anyone help with this one? My Thanks! in advance!

If you're asking if 62304 is a good guide for a software development process, then yes. In general, you should have no issues with FDA or ISO if you follow that guide for a sw only product. It lays out a complete and comprehensive SDLC.

62304 doesn't necessarily prescribe documentation in the nomenclature of FDA or CE. For example, FDA will require a Design History Folder (DHF). Much of what you're doing if you follow 62304 would go into the DHF but you would only know that once you're familiar with 820 as well. CE will require a Technical File which, again, will reference much of what's done if following 62304 but you have to know the correlation. Further, there are required elements that 62304 won't address. For example, a recent change to the MDD requires a clinical evaluation report / literature review. Clearly, not covered by 62304.

There is no prescribed templates for any of the required documents. I'm sure a good search of Cove artifacts will turn up plenty. Once you get a better handle on things, specific questions will trigger better discussion / feedback.

So the bottom line is that 62304 will take you very far for a sw only product, but it's not the end-all in applying for clearance to market. You need to understand specifics of the 510(k) / FDA process and the specifics of the ISO / CE Marking process and understand how the artifacts from the 62304 process fit in.

Hello Yodon,
Thanks a lot for your input. I have been looking into the documentation for the FDA 510(k) in regards to the SDLC process.

However is there any place where I can find documentation process for IEC 62304:2006? Is there a FREE site where I can download it if possible?

Does anyone have a matrix or comparison analysis between FDA 510(K), IEC 62304:2006 and ISO?

That camparison matrix aka chart could really help me assess the gaps between each standard.

Thanks for your help.

regards
Tim

I agree with Yodon, only some minor addition to that.

>>I looked into the ISO/EN IEC 62304:2006 as well the documentations related
>> to FDA 510(k) submission standards. But what would be best route that
>> would incorporate and be acceptable/compatible to both standards?

We are almost talking about the same thing here, 51ok submission requires "only" in case if the Moderate concern the summaryof the software lifecycle dev. plan, the configuration management and maintenance activities.
These are basically the mid level views of you SW DEV Lifecycle SOP (which is hopefully based on 62304).
Okay, SW dev. plan created in 5.1 in 62304 but mainly describes the implementation of 62304 itself during product realization.

>> Are there any Test plan templates that I can use for Test Validation and Verification?
I have an ambiguous and suspicious feeling about this question, because I assume you are asking it to use it for the creation of the 510k V&V Documentation.
Be aware, submitted documentation shall be traceable (URS-SRS-ADC-SDS-TestCases-TestResult), I hope you know "traceable" world what consequences and amount of documentation work brings into the picture. In case not, we will share for sure.

>> My goal is to certify with both standards and find processes that compliment both FDA 510(k) and CE (IEC 62304:2006)
That's almost the same.
62304 is a recognized standard by FDA, CE only recently added this one into its list.

>> Are there any templates that I can use for each step of the process from Research & Analysis to Deisgn and testing etc?
Sorry, but here we can be honest and we do can say what we think, but what I think in case you try to choose a fast looking "pretemplate" way, sooner or later you will be in middle of the great deal of sh*t.
The template shall be linked to your QMS on the Process controll level and when you do those SOPs, than you surely will be confident to make those templates. by yourself and not for last according to the need of your company. Okay, there are regulatory influences, but you recognize those in incorporate them into the template.

I am getting to a long post, so I finish it right now.

br
Sz.

Taimoore said:

However is there any place where I can find documentation process for IEC 62304:2006? Is there a FREE site where I can download it if possible?

Click to expand...

Sorry, don't know of one. But document templates don't really buy you a lot. Focus on content.

Taimoore said:

Does anyone have a matrix or comparison analysis between FDA 510(K), IEC 62304:2006 and ISO?

That camparison matrix aka chart could really help me assess the gaps between each standard.

Click to expand...

Software development (62304) is a subset of the overall product development and, of course, 820 and 13485 take the full product life cycle into account. Table C.1 shows the mapping of (full) 62304 clauses to the related clauses in 13485. You should be able to extrapolate from there where the related documents fit in. For example, Software Development Planning gives rise to a Software Development Plan and that is an expectation that falls under 7.3.1, Design and Development Planning in 13485.

There are numerous mappings between 820 and 13485 if you do a search. You can use that to then see where the documents fall under 820.

Again, though, you still need to consider the full product life cycle; e.g., regulatory filing, complaint handling, etc. to know the full suite of documentation needed (beyond that of the software development and maintenance activities). Sagai makes a good point about how the documentation expectations change depending on the criticality of the softwate. And there's not just the product documents: there's also process documents; e.g., management reviews, etc.

<on soap box> I think one of the difficulties in replying to your question is its breadth. Sagai and I have provided broad responses to your broad questions. There aren't any magic decoder rings here: you have to do your homework to understand how your company can meet the regulations / standards. If someone tells you something and you blindly follow it and then can't get product clearance because the advice was wrong or you misunderstood it, you will only have yourself to blame. There's a wealth of information in the Cove but no one can do the work for you. As you start digging into the processes, posing specific questions to the Cove will likely get you plenty of responses. Glad to help but if you want me to do the work, I'll gladly do that too... at my contracting fees. <off soap box>

I did it anyway, there is a document I did, may also help you.
Any comment, suggestion, correction, addition is more than welcomed for the Document.
br
Sz.

Hello Sagai,
Thanks a lot for the information and sight. I am attaching some documents for comparison matrix. Please review it and let me know.

I am not sure which document/s would be more applicable for a CLASS II (moderate level of Concern) device?

Anyone else who would care to pitch in with their professional insight wisdom would be greatly appreciated.

Thanks

regards
Tim

Hi Tim,

I personally I do not like these comparison charts among standards, they are not complete and misleading.

Make it easier ...

Let me suggest you to check this public website, what Warning Letters were sent to companies by FDA, select your potential competitors and see, what level of issues they were addressed.

http://www.accessdata.fda.gov/scripts/warningletters/wlFilterByCompany.cfm

These WLs were sent AFTER having the 510k approval.

Back to the standard crossmatrix, I would prefer to implement and audit the tailored QMS system according to 21CFR820 (and other relevant 21CFR) using the related FDA recognized standards ( http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm ), THAN submit 510k if I am very sure to succeed, after having approval I think EU sign is almost nothing compared the work you did for 510k. Major difference can be only for Risk Management categories, because in EU there is a corresponding MDD contains slightly different items and categories for the potential Hazard identification than 14971 does. There is a Technical File to assembly it is also different its structure from DHF/DMR/DHR but till that time you will have all on board.
(I have no direct experience with EC signs, only indirect impressions says my last to statements)

Regards
Sz.

510K requires manufacturer to provide evidence of following and complying with quality procedure and process. Manufacturer can select any internationally accepted standard, and IEC 62304 is guidelines, not a standard from FDA. But for medical device, IEC 62304 is preferred since it has risk management part of the process. But CMMI with risk management. Design controls, design review, deisgn history file, design history records are major part of the medical device development. So the selected process should address these.