With the increased Software content in medical devices, FDA announced in December 2017 a new category of medical devices called Software as Medical Device (SaMD).
SaMD developers face several challenges for FDA approval process which was originally geared towards regulating the Hardware centric medical devices. With the new class of medical device software having various combinations of recent technology like Artificial Intelligence AI), Internet of Things (IoT), Machine Learning, Deep Learning, Augmented Reality (AR), Virtual reality (VR), Cloud based services both medical device manufacturers and FDA are facing new set of challenges for safety and compliance requirements.
For Quality and Risk management SaMD depends on the guidelines of ISO 13485 and ISO 14971 respectively, although they need interpretation, implementation, and enforcement specific to the SaMD needs. Additionally, SaMD developers need to follow IEC 62304 for guidelines on Software Development Lifecycle (SDLC) or Application Lifecycle Management (ALM). For the Agile minded development teams, the guidance on Agile Practice for medical device software described in the document AAMI TR45 will be especially useful.
MediDev’s SaMD Lifecycle Management implements all aspects of Quality, Risk, and software development lifecycle management for Medical Device Hardware/ Software and SaMD tightly integrated with each other. The best practices following the guidance described in all the above documents come out of the box ready to use on day one. However, if needed MediDev includes the drag and drop configurability for any organization to customize the processes to their exact needs.
Learn more how MediDev SaMD Lifecycle Management helps in SaMD development, pre- and post-approval processes.