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SaMD Verification and Validation SOP and Plan

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yodon

Staff member
Super Moderator
#2
Why do you feel an SOP is necessary?

62304 does not require a (software) validation plan; only software testing at a system level. In fact, section 1.2 says: (my emphasis added):

This standard does not cover validation and final release of the MEDICAL DEVICE, even when the MEDICAL DEVICE consists entirely of software.

But, since your SaMD is a medical device, you'll still need to do design verification and design validation per 13485. So do your V&V planning per 13485 and leverage any software system testing as Verification. For validation, how do you know your system is meeting user needs and intended use?
 
#3
Why do you feel an SOP is necessary?

62304 does not require a (software) validation plan; only software testing at a system level. In fact, section 1.2 says: (my emphasis added):

This standard does not cover validation and final release of the MEDICAL DEVICE, even when the MEDICAL DEVICE consists entirely of software.

But, since your SaMD is a medical device, you'll still need to do design verification and design validation per 13485. So do your V&V planning per 13485 and leverage any software system testing as Verification. For validation, how do you know your system is meeting user needs and intended use?
I think question is not whether 62304 requires Validation Plan. I understand 62304 does not cover Validation and is limited to Verification. I was more looking for sample SOP of SaMD verification and validation and sample V&V Plan for SaMD as suggested by
General Principles of Software Validation; Final Guidance for Industry and FDA Staff and also in 82304
 

Tidge

Trusted Information Resource
#4
I think part of the larger point @yodon is trying to make is that 62304 outlines a risk-based approach to the development of software in (or as) a Medical Device. 62304 is not intended to cover the validation of a Medical Device.

62304 is a valuable standard (even by consensus!), but it is important to note that it is a process standard, with the presumption being that following this standard within a larger framework of a 14971-compliant process for analyzing risks (to patients, users), that an appropriate amount of effort will be done to allow the software be understood within the context of the risks relating to the finished medical device.

Personally, I don't think an SOP for validation of a medical device needs to do much more than require validation, with appropriate levels of pre-approval of the plan prior to execution and approved post-execution review of results (in the form of a report). It's always possible for an SOP to be more explicit, it just depends on how specific you want/need to be. For example, if you have been having ineffective validation because of too few users in validation, you could be tempted to be more explicit about properly designed study designs. This sort of thing would not be part of a 62304-driven development.
 
#5
Well its my Own preference to have SOP on V&V that give more clarity on how V7V should be carried out. I understand 62304 and its risk based development and all.
I think part of the larger point @yodon is trying to make is that 62304 outlines a risk-based approach to the development of software in (or as) a Medical Device. 62304 is not intended to cover the validation of a Medical Device.

62304 is a valuable standard (even by consensus!), but it is important to note that it is a process standard, with the presumption being that following this standard within a larger framework of a 14971-compliant process for analyzing risks (to patients, users), that an appropriate amount of effort will be done to allow the software be understood within the context of the risks relating to the finished medical device.

Personally, I don't think an SOP for validation of a medical device needs to do much more than require validation, with appropriate levels of pre-approval of the plan prior to execution and approved post-execution review of results (in the form of a report). It's always possible for an SOP to be more explicit, it just depends on how specific you want/need to be. For example, if you have been having ineffective validation because of too few users in validation, you could be tempted to be more explicit about properly designed study designs. This sort of thing would not be part of a 62304-driven development.
Defnitely SOP for Validation can be more than that on how and where you draft protocol, if clinical trial requires then what should approach, what should be validation rigor, what statistical technique should be used, how do you execute the test and how do you manage discrepancy. So it better to have seperate SOP than everything specifying in the Design Control or Software Development SOP
 

Tidge

Trusted Information Resource
#6
This is my opinion: If you attempt to standardize a particular statistical technique (or verification methodology) the next thing you will have to write an SOP for is for handling process deviations.
 
#7
This is my opinion: If you attempt to standardize a particular statistical technique (or verification methodology) the next thing you will have to write an SOP for is for handling process deviations.
Yes off Course that's my plan to have separate SOP on statistical technique as well.
 

Ninja

Looking for Reality
Staff member
Super Moderator
#9
I'm not in Medical, nor in any way associated or familiar with Medical standards...but I can read forums...

Just so it doesn't get lost in translation and tact:
Well its my Own preference to have SOP on V&V that give more clarity on how V7V should be carried out.
Yes off Course that's my plan to have separate SOP on statistical technique as well.
@yodon and @Tidge, two experienced and knowledgeable members in this area said (very politely...perhaps too politely to get through),
"That's a really bad idea. Don't do that."

HTH, best of luck whichever way you choose to go.
 
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