Medical Device Software (Firmware) Validation with using IEC62304

S

sl344

#1
Dear all,

The firmware I 'm working on is developed using 62304. However, since 62304 does not cover software validation. I'm done with all the software verification activies, how should I handle the software validation? please help. thanks.
 
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sagai

Quite Involved in Discussions
#3
Hi,
what is it mean that you are using 62304?
Is your medical device will be marketed in the US?
Regard
Szabolcs
 
S

sl344

#4
the firmware was developed following 62304 processes. No, the device will be marketed in EU only.
 

Pads38

Trusted Information Resource
#5
The validation requirements are specified in EN 60601-1:2005 clause 14 (which replaces 60601-1-4).

It overlaps with 62304 but is complimentary.
 
S

sl344

#7
Thanks all for your replies. I reviewed the FDA software validation guidance. Based on the definition in the guidance below. I feel the only thing I really need to do for software validation is to make sure the SRS conforms to the users need, which could be done through traceability analysis. As the firmware was developed following 62304 processes, all the tasks below SRS have been completed such as design, implementation, unit testing, system level testing, etc.

We did not go through the 60601 Clause 14 PEMS path because the device was determined NOT a PEMS, given the fact when the firmware fails, it does not produce an unacceptable risk.

How do you think?

thanks,
Lori



Software validation is a part of the design validation for a finished device, but is not separately defined in the Quality System regulation. For purposes of this guidance, FDA considers software validation to be "confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled." In practice, software validation activities may occur both during, as well as at the end of the software development life cycle to ensure that all requirements have been fulfilled. Since software is usually part of a larger hardware system, the validation of software typically includes evidence that all software requirements have been implemented correctly and completely and are traceable to system requirements. A conclusion that software is validated is highly dependent upon comprehensive software testing, inspections, analyses, and other verification tasks performed at each stage of the software development life cycle. Testing of device software functionality in a simulated use environment, and user site testing are typically included as components of an overall design validation program for a software automated device.
 

Pads38

Trusted Information Resource
#8
I tried to use the argument that as no safety function was involved I did not have to consider clause 14 (of 60601-1:2005). But our notified body pointed out the Essential Requirement of the directive.
Essential Requirement 12.1a
For devices which incorporate software....the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification.
However, I agree that it should be possible to effectively validate your item by confirmation that all parts of the SRS have been delivered as stated.
 

sagai

Quite Involved in Discussions
#9
I do not think the SRS can be the basis of the validation activity.
Regards
Szabolcs
 
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v9991

Trusted Information Resource
#10
1) I agree with Sagai., SRS may not be good idea to base your validation approach. instead focus on URS.
but basing three-way-traceability-matrix for proving/demonstrating validation of application is a good idea.(URS vs Design spec vs test scripts) But that will include other aspects as test plan/strategy, functional/technical design, test scripts etc., which are apparently taken care.


2) I agree with Notified body, Pads38, however they are evaluated for PEMS & not leading to unacceptable risk, the product has to be demonstrated/evidenced with actual results. ( we cannot always rely upon design; nor do we can wait till product performance/feedback from market complaints/failures etc.,)
:2cents:
 
Last edited:
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