How to Get Started with Software as a Medical Device (SaMD)

Getting started with Software as a Medical Device (SaMD) requires a proper approach to maintaining necessary design, development, testing, and quality control standards. Understanding the importance of each aspect throughout a SaMD’s lifecycle provides the best opportunity to ensure patient safety and regulatory compliance successfully.
 
This whitepaper discusses the software development lifecycle (SDLC), quality management systems, and post-market surveillance required to achieve the best possible outcome for SaMD.