Agile, fast,efficient and compliant medical device software compliance.
More than just a "tick-box" approach to compliance, I can help you write a an IEC62304 compliant Design & Development plan which is your operational playbook.
High velocity code needs high velocity documentation. With doc-as-code you can deploy documentation with your code using the same toolchain.
Agile is about increments starting with your first release. Use the power of Agile for efficient and transparent compliance on an Agile Toolchain.
Please review my articles and webinars below..
In this Webinar I will demonstrate how to achieve higher efficiency and coordination with development, quality, regulatory & documentation teams by using one backlog for
In this Webinar we use the metaphor of a formula 1 race car to demonstrate the dynamics of cloud SaMD deployment. Unlike traditional MedTech Design