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What is the intended purpose of a medical device, what are the needs of the users, and under which circumstances are they going to use the device?
From writing the intended purpose document to creating a traceability matrix, Technolution has the expertise to help your organization assess the product requirements to a medical device. Product requirements should, among other things, be unambiguous, consistent, verifiable and feasible.
We can help to verify the requirements through verification test plans, verification test protocols, verification tests and verification test reports and to validate user needs through usability engineering activities. Furthermore, we can create a traceability matrix to make sure that user requirements are traced and documented with test cases.