Understanding The Role Of IEC 62304 in Medical Device Software Development
One of the major reasons behind the growth of medical sector is the integration of advanced software with the medical devices . The se software are used as an integral component of a medical device, application on mobile, or in a standalone device used in health care treatment or diagnosis. However, to ensure that the software build by medical device software companies is safe and reliable for users, it needs to follow an international standard. IEC 62304 (medical device software) for software life cycle processes is a standard given by both European and the US authorities that specifies life cycle requirements for the development of a medical software. S oftware development companies use this standard as a benchmark to comply with regulatory requirements and deliver competent medical device software. IEC 62304 standard needs to be applied while building a medical device software which is ...