Videos

Development Stages

When should V&V really start in medical device development?

Leave a Comment / News, Risk Management, V&V Testing, V2026, Videos

V&V is traditionally viewed as the final phase of medical device development, but successful teams begin preparing for it from the start. While formal, documented Verification & Validation occurs at the end to demonstrate compliance, effective development integrates testing throughout. This includes developing test methods, building tools, and evaluating prototypes early and often. Waiting until […]

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Managing Medical Devices That Are Never Finished

Embracing Change: Managing Medical Devices That Are Never Finished

Leave a Comment / Medical Device Development, V2024, Videos

“Embracing Change: Managing Medical Devices That Are Never Finished” was recorded in July 2024 as part of Voler Systems’ webinar series How do we manage upgrades to a new medical device after product launch? If you don’t expect to ever make changes to the product then this may not be a concern at all. However,

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Challenges of Product Teams Developing Complex Medical Devices

Real-life Challenges of Product Teams Developing Complex Medical Devices

Leave a Comment / Medical Device Development, V2023, Videos

Presented by Voler Systems, Russ Singleton, and Aaron Joseph The challenges that product development teams and leadership face have to do with more than just technology. Complex medical devices take longer to develop, have bigger teams, and require a wider variety of expertise than developing simpler products. The panel of medical device experts share how

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Agile Design Controls V&V

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

Leave a Comment / Events, Lean & Agile, News, V&V Testing, V2019, Videos

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

5 Comments / Events, Lean & Agile, Medical Device Development, Risk Management, V2019, Videos

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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ADC-Webinar201902

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

4 Comments / Events, Lean & Agile, News, V2019, Videos

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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10xMedicalDeviceConference2017

Why Haven’t More Medical Device Companies Embraced Agile?

2 Comments / Events, Lean & Agile, Videos

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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Accelerating Medical Device Development While Improving Compliance

Leave a Comment / Events, Lean & Agile, Medical Device Development, Software Development, Videos

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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