Article
Roundtable Chapter 1 – The One Where the Device Was Only Half the Story
This post was previously on the Pathfinder Software site. Pathfinder Software changed its name to Orthogonal in 2016. Read more.
Agile emphasizes minimal documentation, a lot of verbal communication and rapid feedback loops to increase software quality, reduce waste and speed development.
FDA regulations run counter to this approach, implying a heavyweight waterfall process with big design up front and heavyweight documentation.
Can you get the benefits of agile in an FDA regulated environment? Yes.
Orthogonal’s Michael Walkden and Tavi Scandiff- Pirvu will speak on “Agile for Medical Software: Faster, Better Results in FDA Regulated Environments” in an event co organized by the Chicago Agile Project Management group and the Chicago Health 2.0 meetup group on April 26th. Michael and Tavi will share the approach that Orthogonal has found effective for medical software projects in an FDA regulated environment, including pitfalls to avoid and best practices based on their real world experience.
To sign up, register at: https://www.meetup.com/Chicago-APM/events/16597253/
Related Posts
Article
Roundtable Chapter 1 – The One Where the Device Was Only Half the Story
Article
Roundtable Prologue – The One Where the Algorithm Couldn’t Sell Itself
Article
Managing Emerging Risks in SaMD: Strategies for 2025 and Beyond
Article
Emerging Opportunities in SaMD and MedTech for 2025