The medical device validation and performance is important from the market point of view since a validated product is complying with the safety specifications proposed by international and national regulations simultaneously meeting the requirements of the different regulations for commercialization. Complying with these requirements implies that the product can be commercialized generating profits for designers, producers, and transformers of medical devices.
From biomedical engineering, it is intended to associate the term validation with understandable concepts that allow a definition of it from applied engineering research. The requirements demanded by international regulations were linked through standards such as ISO 13485: 2003, with solutions proposed from engineering.
Medical Device Validation Levels
It is concluded that the medical device validation should be developed at two levels: the pre-market evaluation; where activities should be carried out to evaluate economic viability, technical viability, ethical and legal viability, the study of epidemiological risk factors and clinical product trials; and a post-market evaluation; where evaluation activities must be carried out on the traceability of the process (internal and external audit), post-market economic viability and product sustainability over time.