Lean & Agile

Agile Design Controls Part 3: Paperless V&V to Support Rapid Design Iterations of Medical Devices

https://vimeo.com/333499493 This webinar describes how to support rapid design iterations of medical devices while still maintaining systematic, rigorous V&V testing. Traditional approaches to V&V are often slow, inefficient, and break down with repeated testing. Learn how to configure modern SW tools to manage testing of a large number of requirements [...]

By |2020-06-24T10:24:29-07:00May 10th, 2019|Events, Lean & Agile, News, V&V Testing, V2019, Videos|0 Comments

Agile Design Controls Part 3: Paperless V&V to Support Rapid Design Iterations of Medical Devices

April 30, 2019 at 9am PST (5pm CET) This webinar describes how to support rapid design iterations of medical devices while still maintaining systematic, rigorous V&V testing. Traditional approaches to V&V are often slow, inefficient, and break down with repeated testing. Learn how to configure modern SW tools to manage [...]

By |2019-04-08T09:50:48-07:00April 8th, 2019|Events, Lean & Agile, V2019|0 Comments

Agile Design Controls Part 2 Webinar: Dynamic Risk Management for SW-Intensive Medical Devices

https://vimeo.com/326954860 Agile Design Controls Part 2 Webinar: Dynamic Risk Management for SW-Intensive Medical Devices 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 [...]

Agile Design Controls Part 2 Webinar: Dynamic Risk Management for SW-Intensive Medical Devices

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 [...]

By |2019-04-02T18:49:52-07:00February 18th, 2019|Events, Lean & Agile, News, V2019|1 Comment

Webinar: Agile Design Controls: How to Support Rapid Design Iterations for SW-Intensive Medical Devices

https://vimeo.com/317634638 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 [...]

By |2019-06-05T13:42:32-07:00February 18th, 2019|Events, Lean & Agile, News, V2019, Videos|4 Comments

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 management, test management, and defect tracking allow product [...]

By |2019-02-07T08:32:21-08:00January 23rd, 2019|Events, Lean & Agile, V2019|0 Comments

FDA Software Guidances and the IEC 62304 Software Standard

“One approach to satisfy two sets of rules” As stated in the last blog post, there are two sets of rules for SW regulation—twice the rules, twice the confusion. My recommendation is to base your software development procedures on the IEC 62304 Standard, which is easier to understand, and then [...]

The Two Minds for Successful Product Development

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 [...]

By |2018-05-03T17:50:52-07:00April 25th, 2018|Lean & Agile, Medical Device Development|0 Comments

Why Haven’t More Medical Device Companies Embraced Agile?

https://youtu.be/1mU2qo7GuT0 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 [...]

By |2019-03-06T07:13:11-08:00May 30th, 2017|Events, Lean & Agile, Videos|2 Comments