Coauthor has been developed by Hindsight Software, a provider of software development tools and a company that’s working to merge compliance with modern software development practices.
While software developers can rely on tools like AI for policy creation when developing their new products, Alan Parkinson, the founder of Coauthor, warns, “There is a lot of hype about AI helping to create policies and plans for medical device manufacturers’ QMSs. Even if the generated documents were compliant, it doesn’t consider how software developers prefer to work or help with configuring development tooling and software applications to support the process and policies.”
Coauthor looks to provide a set of pre-built IEC 62304-compatible policies, SOPs, and plans aligned with modern software practices. It goes beyond just policy generation by configuring development tools to enforce these policies and plans.
Due to Coauthor's collaboration with regulatory compliance and medical standards experts (Fieldfare Consulting) to develop these policies, it claims that its product meets regulatory requirements.
There has been a historical divide between compliance and software developers, and Coauthor has taken a developer-first approach, fully integrating with GitHub. Through comments and Pull Request checks, it highlights policy violations to developers in real-time, ensuring immediate compliance feedback.
Traditionally, compliance processes have been carried out at the end of the development lifecycle, leading to increased costs, delays, and more work for the developer. But in an attempt to improve their software development, finance companies have taken a different approach. These developers have begun incorporating compliance into the early stages of development and it has proven to be a game-changer - resulting in faster product releases and enhanced developer productivity.
From the very inception of a SaMD project, the Coauthor tool can ensure its compliance and maintain that compliance throughout the development lifecycle. This significantly reduces the time required by regulatory affairs teams to prepare submissions for notified bodies, cutting down from months to mere days or weeks.
Additionally, Coauthor aids in submission preparations by automatically gathering evidence from software development tools.
According to Richard Koch, SaMD IEC62304 Consultant at Koch SaMD, “The future of Agile software development will be a closer merging of project management and code management tools.”
Coauthor was presented earlier this month at the Med-Tech Innovation Expo held annually at the NEC in Birmingham.
