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Hi all,
We have a Class IIa medical device that received CE mark. The device approved for intended use A. and now the company would like to extend the scope to cover intended use A and B. This is done by adding a software module B into the original software. As for validating this software, we have conducted a small trial with 50 subjects and utilized the cross-validation method to teach to software to do data analysis and validate the software.
Does anyone know if such change will require a clinical trial? I know we will have to do a clinical evaluation, update the risk management file, and conduct software validation. Am I missing anything here?
Thank you in advance for every inputs!
We have a Class IIa medical device that received CE mark. The device approved for intended use A. and now the company would like to extend the scope to cover intended use A and B. This is done by adding a software module B into the original software. As for validating this software, we have conducted a small trial with 50 subjects and utilized the cross-validation method to teach to software to do data analysis and validate the software.
Does anyone know if such change will require a clinical trial? I know we will have to do a clinical evaluation, update the risk management file, and conduct software validation. Am I missing anything here?
Thank you in advance for every inputs!