Medical Software Requirements at the New Cuban Regulations for Evaluation and State Control of Medical Devices

摘要

Paper discusses aspects of newly adoption of the Medical Software Requirements as annex of Cuban Regulations for Evaluation and State Control of Medical Devices, incorporate the strategies defined in the health policy and adopts a legislative dimension, in agreement with its own precepts and formulations. Defines the concepts of state control and evaluation of the medical software and adopts the medical software requirements, according with technological advances, and roll of software in safety. We should know that in the USA FDA's analysis of 3140 medical device recalls conducted between 1992 and 1998 reveals that 242 of them (7.7%) are attributable to software failures. Of those software related recalls, 192 (or 79%) were caused by software defects that were introduced when changes were made to the software after its initial distribution. Examples of established requirements: The medical devices being or including medical software must be designed to guarantee their function and efficacy according to the use they are intended to, complying with the specific requirements. Some others requirements should be considered for software evaluation: The existence and integrity of the information related to the medical software product, including: Critical analysis or risk classification, Risk analysis, Applied test cases, Testing plan, User documentation. The requirements keep in mind adoption of the international standard ISO/IEC 9126-1 and therefore the quality characteristics of software products as media to demonstrate effective and safety. At date, regulations about medical software requirement have been successfully applying as part of evaluation of medical software.