What’s Wrong with the Proposed FDA MDDS Rule
It is foreseeable… that an MDDS could initiate a command to a medical device that results in unintended operation of the device.
About: Peter
Profile:
Peter Kelley is Director of Compliance at Capsule, with more than 20 years experience developing medical devices and software. He has worked for some of the largest companies, including GE Healthcare and Hewlett-Packard Medical, and has been instrumental to the success of startups such as Sentillion and now Capsule. His professional interests are in the software development process, and for the past several years he has focused on regulatory compliance and how it affects the development process.
