This is the last article of a three-part series on non-product software risk assessment, validation and testing. Download the entire series in one convenient PDF. Part 1: NPS Risk Assessment for Medical Device Manufacturers Part 2: Non-Product Software (NPS) Validation for Medical Device Manufacturers Part 3: This article There’s a lot of preparation involved in validating non-product software, and the actual testing is just one of many activities. Much like other technical testing activities, well-executed testing is completely dependent on […]

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This is the second article of a three-part series on non-product software risk assessment, validation and testing. Download the entire series in one convenient PDF. Part 1: NPS Risk Assessment for Medical Device Manufacturers Part 2: This article Part 3: Writing NPS Protocols and Testing for Medical Device Manufacturers   Compiling a comprehensive list of all non-product software (NPS) and conducting an initial risk assessment are critical first steps in the validation process. While low-risk software likely won’t require a […]

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