Videos

Agile Design Controls V&V

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

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 with multiple retesting and with automatic …

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Agile Design Controls Part2

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

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 …

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

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 …

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Newsletter V. 2018 Issue 3

My Notes on CyberSecurity I learned a lot about the latest trends in cybersecurity and how to protect medical devices and hospitals at the Connected Devices: CyperSecurity & Compliance conference this week hosted in San Francisco. Upcoming Events Agile Design Controls: How to Support Rapid Design Iterations for Software-Intensive Medical Devices In this webinar I’ll …

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Why Haven’t More Medical Device Companies Embraced Agile?

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. …

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video

Accelerating Medical Device Development While Improving Compliance

If you missed Aaron Joseph’s talk “Accelerating Medical Device Development While Improving Compliance”, the material is available as a video. He explores how to accelerate medical device development with lean and agile methods. Companies in multiple industries have found that lean and agile methods speed up their product development while simultaneously improving quality and cutting …

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