If you are interested in turning your research into a software medical device, this talk will provide you with valuable insight in how to get started.
Medical device regulation can seem overwhelming, but with guidance and the right processes in place, it is possible to gain FDA 510(k) clearance and CE Marking in a relatively short timeframe.
This talk provides an overview of the lifecycle of a creating software medical device. It will introduce the different stages of the process including setup, quality management systems, specification, design, implementation, verification, validation, rollout and maintenance.
The talk is delivered by Dr Robert Merrifield who has created CE Marked and FDA 510(k) cleared medical software that has been used to diagnose over 100,000 patients worldwide.