Greater scrutiny and more validation.
Given the critical nature of the functions performed by today’s medical devices, greater scrutiny along with the need for more certifiable software is on this rise. There is more interest today in government standards such as FDA 510K and IEC 62304 for medical device software. Enhanced scrutiny from government agencies can introduce unexpected delays – or even jeopardize the commercial release of a medical device. Getting through the FDA review as quickly as possible requires a clear understanding of the development standards, documentation, and testing that is now expected for medical devices. This paper discusses regulatory trends software developers should consider and how to successfully design medical devices that comply with the IEC 62304 standard.
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