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FDA Validation of COMSOL

Posted 04.09.2009, 13:56 GMT-4 2 Replies

Jason Glithero
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Does anyone in the COMSOL community use analytical tools to drive design of medical devices?

If you use a CAD pacakge and analytical package, are they validated when installed on your network?

Our QA and IT group is pushing back claiming that the design tool need to be validated although we have a systems in place that contain the drawings and final reports of the actual device verification testing?

TIA,

-Jason

2 Replies Last Post 03.03.2020, 14:16 GMT-5
COMSOL Moderator

Hello Jason Glithero

Your Discussion has gone 30 days without a reply. If you still need help with COMSOL and have an on-subscription license, please visit our Support Center for help.

If you do not hold an on-subscription license, you may find an answer in another Discussion or in the Knowledge Base.

DW
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Posted: 8 years ago 28.11.2016, 19:59 GMT-5
Hello,

There is a report related to this topic:
"Reporting of Computational Modeling Studies in Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff, Document issued on: September 21, 2016, U.S. Department of Health and Human Services, Food & Drug Administration."

www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM381813.pdf

-DW

Hello, There is a report related to this topic: "Reporting of Computational Modeling Studies in Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff, Document issued on: September 21, 2016, U.S. Department of Health and Human Services, Food & Drug Administration." http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM381813.pdf -DW
Jeff Hiller COMSOL Employee

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Posted: 5 years ago 03.03.2020, 14:16 GMT-5
Updated: 5 years ago 11.03.2020, 15:31 GMT-4

Best practices in V&V, promoted by organizations like the FDA and ASME, point to (at least) two verification steps: 1/ checking that the software you use performs on your machine the same way as it does on the developers' (This is frequently referred to as Software Quality Assurance, or SQA) and 2/ ascertaining that the software returns results that are consistent with established and trusted, exact or approximate, solutions for the same equations (This is referred to as Numerical Code Validation, or NCV). Additionally, they'll recommend that you demonstrate that the equations you chose to solve in the software are appropriate for the real-word situation; That is validation.

COMSOL recently added to our website a page that gathers well over a hundred verification and validation models and their documentation. Those models can be filtered by discipline or by module, as well as searched through via a free word search. The results produced by those models are in various ways checked against analytical solutions, or semi-analytical solutions, or numerical solutions obtained by other methods, or experimental data reported in the literature. because we provide pre-computed solutions for all those models, they can be used to document your NCV and SQA efforts to regulatory authorities.

Best,

Jeff

-------------------
Jeff Hiller
Best practices in V&V, promoted by organizations like the FDA and ASME, point to (at least) two verification steps: 1/ checking that the software you use performs on your machine the same way as it does on the developers' (This is frequently referred to as Software Quality Assurance, or SQA) and 2/ ascertaining that the software returns results that are consistent with established and trusted, exact or approximate, solutions for the same equations (This is referred to as Numerical Code Validation, or NCV). Additionally, they'll recommend that you demonstrate that the equations you chose to solve in the software are appropriate for the real-word situation; That is validation. COMSOL recently added to our website [a page](https://www.comsol.com/verification-models) that gathers well over a hundred verification and validation models and their documentation. Those models can be filtered by discipline or by module, as well as searched through via a free word search. The results produced by those models are in various ways checked against analytical solutions, or semi-analytical solutions, or numerical solutions obtained by other methods, or experimental data reported in the literature. because we provide pre-computed solutions for all those models, they can be used to document your NCV and SQA efforts to regulatory authorities. Best, Jeff

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