Article

Agile for FDA Medical Software Seminar

Bernhard Kappe
Bernhard Kappe

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

Talk

Gathering Medical Device Data & Evidence: Webinar

White Paper

Software as a Medical Device (SaMD): What It Is & Why It Matters

Talk

What Medical Device Software to Develop Under QMS: Webinar

Article

SaMD Cleared by the FDA: The Ultimate Running List