Overview Software as a Medical Device (SaMD) is an often misunderstood area which can lead to either under or overestimating requirements, such as cybersecurity, resilience, data storage and verification and validation needs. This will impact your choices for AWS architectures, tools, landing zones and security practices. Understanding these requirements, how to meet the requirements inside, including technically within AWS is often complex but will enable you to successfully bring a high value SaMD to market rapidly.

Topics In this half day workshop, aimed at those who are exploring becoming a SaMD developer, we collaboratively discuss, what SaMD is and how it is different from normal software, how to meet these requirements and how to implement solutions within AWS.

Outcomes From this workshop you will have a clear understanding of what your regulatory requirements are, and how to address them both from a process and technical perspective for your SaMD.