Ease the Heartache of Medical Device Software Certification
July 08, 2022
A software functional safety standard such as that prescribed by IEC 62304 with its many sections,clauses and sub-clauses may at first seem intimidating. However, once broken down into digestible pieces, its guiding principles offer sound guidance in the establishment of a high quality software development process. Such a process is paramount for the assurance of true reliability and quality—and above all the safety and effectiveness of medical devices.
The increasing demand for the connectivity of medical devices places a new emphasis on the need to respond quickly and effectively to vulnerabilities discovered or compromised after product launch, demanding that the high standards of the development process must be upheld not only leading up to initial product release but into maintenance and beyond.
The “best practise” guidance given by the standard is therefore something to be embraced, not feared. When complemented by a comprehensive suite of tools for analysis and testing, it can smooth the way for development teams to work together to effectively develop and maintain even large projects with confidence in their quality.