Software is an essential and critical factor of product safety and functionality, either as a separate device or as an integral component of a medical device. A software validation includes a statement on the software’s ability to reach planned results and is perpetual part of the conformity assessment procedure. Manufacturers are required to ascertain and to verify in the product documentation that the installed software adequately fulfils its intended purpose. The medical intended purpose is a decisive factor, which needs to be clarified in advance.
Software validation according to IEC 62304 / IEC 60601-1 Cl.14 requires high level of expert knowledge in a variety of fields. This includes experience and knowledge about the product, product development, its usage and its operational environment; experience and knowledge in process development, process control, risk management as well as quality assurance. In certain cases, it is required to contract an external company with the above mentioned qualifications and experience.