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We will have a counter as part of a medical device. Counter is a module that is run by software. The supplier does not have documentation statiing the test results of any testing. Just that the product has been in manufacturing for more than 5 years. I am following 60601-1-4:1996 for compliance. I am looking to do the following (will this be in compliance)
“verify” at multiple points. For example, the design is verified against the requirements and software is verified against the design. Test that system-level requirements were met by running a system verification test of the completed product.
Validation, by “real” end users (in controlled settings) and only done on the final product
“verify” at multiple points. For example, the design is verified against the requirements and software is verified against the design. Test that system-level requirements were met by running a system verification test of the completed product.
Validation, by “real” end users (in controlled settings) and only done on the final product