This webinar describes a dynamic approach to managing risk analysis and risk controls to keep up with fast moving product development teams. Learn the nuts and bolts of how to integrate risk management into the overall product development workflow using a requirements management SW tool to create a more flexible and rigorous approach than standalone […]
Agile Design Controls: How to Support Rapid Design Iterations for SW-Intensive Medical Devices How to examples using Matrix ALM and JIRA Traditional methods for medical device development cannot keep up with the challenges of modern, software-intensive medical devices, which need to be developed iteratively and to be regularly updated after launch. Software tools for requirements
How to examples using Matrix ALM and JIRA Traditional methods for medical device development cannot keep up with the challenges of modern, software-intensive medical devices, which need to be developed iteratively and to be regularly updated after launch. Software tools for requirements management, test management, and defect tracking allow product development teams to make rapid
[updated NOV 2023] “One approach to satisfy two sets of rules” for medical device software As stated in the last blog post, there are two sets of rules for medical device software—twice the rules, twice the confusion. My recommendation is to base your software development procedures on the international IEC 62304 standard, which is easier
FDA Software Guidances and the IEC 62304 Software Standard Read More »
Aaron Joseph and Roger Tang, PhD, Principal at HR Tang Consulting A successful product development process for innovative products is naturally comprised of two mindsets. Early in the product development process, where the uncertainty is the highest, the team’s focus is on rapid learning to close knowledge gaps. These knowledge gaps are those that are
The Two Minds for Successful Product Development Read More »
This short video provides an overview of Agile methods and an in-depth discussion of the practical considerations for satisfying regulatory requirements. A panel of three medical device professionals, with decades of experience across dozens of medical device companies, provide an in-depth overview of the practical realities of adopting Agile methods for medical device software development.
Why Haven’t More Medical Device Companies Embraced Agile? Read More »
Here are some good online resources: http://www.leanprimer.com/downloads/lean_primer.pdf – good overview of lean principles written by two software management consultants (Craig Larman and Bas Vodde) who include aspects of software agile methods as well. http://theleanthinker.com/ – a blog by Mike Rother with lots of good observations and real-life issues involved in changing an organization to lean http://www.lean.org/ – Lean Enterprise
Suggested Resources for Lean and Agile Product Development Read More »
“Agile” consists of a philosophy as well as multiple methods. The most well-known method and what most people associate with agile is the highly iterative scrum method, where scrum teams operate in 2-4 week sprints with daily meetings (scrums). Other agile methods are test-driven development, continuous integration, automated unit testing, planning poker, and pair programming.
Challenges Adopting Agile Methods for Medical Device Software Read More »
If you missed Aaron Joseph’s presentation on “Accelerating Medical Device Development with Lean and Agile Methods”, you can get the slides at http://www.slideshare.net/AaronJoseph7/lean-agile-feb2017patcaajosephss In his talk he shares how medical device companies can take advantage of lean and agile methods for speeding up hardware and software development if they understand how to adapt their quality system
Accelerating Medical Device Development with Lean and Agile Methods Read More »
