Newsletter V. 2019 Issue 2

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Have employees new to medical devices?

I offer practical training on Medical Device Design Controls either on site or at a public workshop.

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Agile Design Controls

This is a three part recorded webinar series that illustrates a flexible and rigorous approach to managing design controls for software-intensive medical devices.  I teamed up with software experts from Matrix Requirements to explain the methods with examples using the Matrix ALM and Jira software tools.

Part 1: How to Support Rapid Design Iterations for SW-Intensive Medical Devices

Part 2: Dynamic Risk Management for SW-Intensive Medical Devices

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

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Additional V&V Resources

Agile Med Dev

For straightforward, practical advice on testing medical device software, I really like this blog by Julien Zaegel:  Medical Device Software Testing

He describes testing from a software engineer’s viewpoint, with considerations for efficiency and flexibility and not just compliance (hence the “agile” part).

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V&V Flowchart

The flowchart provides a “5,000 foot view” of design verification and validation and emphasizes dependencies on different activities.

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