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Hi All,
I'm having a challenging time with understanding what the difference between bench testing or pre-verification testing compared to formal verification testing with respect to how it relates to medical device development?
My interpretation is that the term bench testing and pre-verification are used to describe 'verification' activities that are conducted on prototypes that are under design control but are not yet actual production product that is to be marketed or submitted for regulatory agency approval. So in essence, it is a type of development verification activity. Since this testing and type of verification is conducted during development, it can be viewed as the verification activities that an organization determines are necessary in order to document and verify that a prototype is ready to be used in a pre-clinical, early feasibility study (IRB), IDE (FDA), or pivotal study.
Obviously, not all requirements or risk will be understood or captured early in the development process and therefore not all verification activities required for the final product will be fully understood until later in the process. My understanding is that this is in part why independent parties (IRB's, FDA IDE, etc.) play a hand a reviewing and approving clinical study devices.
So to summarize, the way I'm viewing this is that;
Bench Testing/Pre-Verification --> Used on prototypes --> Testing conducted is inclusive of best effort determination of necessary requirements that developer has determined is needed to ensure function and patient safety --> Independent parties (FDA, IRB's) are the gates that determine that inputs and outputs identified and the planned and executed verification activities are appropriate to move forward with a prototype study.
Formal Verification --> Used on product --> Testing is inclusive of all requirements. FDA is gate that reviews that all inputs and outputs meet the regulatory requirements for the production design.
Is the above understanding consistent with how others view the difference between bench testing and verification?
I'm having a challenging time with understanding what the difference between bench testing or pre-verification testing compared to formal verification testing with respect to how it relates to medical device development?
My interpretation is that the term bench testing and pre-verification are used to describe 'verification' activities that are conducted on prototypes that are under design control but are not yet actual production product that is to be marketed or submitted for regulatory agency approval. So in essence, it is a type of development verification activity. Since this testing and type of verification is conducted during development, it can be viewed as the verification activities that an organization determines are necessary in order to document and verify that a prototype is ready to be used in a pre-clinical, early feasibility study (IRB), IDE (FDA), or pivotal study.
Obviously, not all requirements or risk will be understood or captured early in the development process and therefore not all verification activities required for the final product will be fully understood until later in the process. My understanding is that this is in part why independent parties (IRB's, FDA IDE, etc.) play a hand a reviewing and approving clinical study devices.
So to summarize, the way I'm viewing this is that;
Bench Testing/Pre-Verification --> Used on prototypes --> Testing conducted is inclusive of best effort determination of necessary requirements that developer has determined is needed to ensure function and patient safety --> Independent parties (FDA, IRB's) are the gates that determine that inputs and outputs identified and the planned and executed verification activities are appropriate to move forward with a prototype study.
Formal Verification --> Used on product --> Testing is inclusive of all requirements. FDA is gate that reviews that all inputs and outputs meet the regulatory requirements for the production design.
Is the above understanding consistent with how others view the difference between bench testing and verification?