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A medical device technical file is a comprehensive document that contains all the technical information and data related to a medical device, such as design, manufacturing, testing, clinical evaluation, and risk management.

The FDA issued the Software as a Medical Device: Clinical Evaluation final guidance to describe an internally agreed upon understanding of clinical evaluation and principles for demonstrating the safety, effectiveness, and performance of Software as a Medical Device among regulators in the International Medical Device ...

So, the software in a medical device (SiMD) is as critical a component as the healthcare equipment itself. Software solutions that do not reside in a medical device but are used for medical purposes are called software as a medical device (SaMD).

A device master record (DMR) contains all of the information and specifications needed to produce a medical device from start to finish, including instructions for all manufacturing processes, drawings, documented specifications and labeling and packaging requirements.

?Software as a Medical Device? (SaMD) is defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device. ? However, some countries have their specific definitions, and in the EU, the term medical device software (MDSW) is used.

The International Medical Device Regulators Forum (IMDRF) defines SaMD as ?software intended for one or more medical purposes that perform those purposes without being part of a hardware medical device.?

Software as a Medical Device, or SaMD, can be described as a class of medical software designed to carry out one or more medical functions without the need for actual hardware. This can comprise of software or applications intended to treat diagnose, cure, mitigate or prevent disease.