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 management SW tool to create a more flexible and rigorous approach than standalone spreadsheet methods.  

A panel of software and process experts, with decades of experience across dozens of medical device companies, will describe the practical realities of complying with the IEC 62304 and ISO 14971 standards while supporting rapid design iterations.  The webinar will illustrate this modern, flexible approach with examples using the Matrix ALM and Jira software tools.

About the Speakers:

• Arnaud Alberts, Growth Manager at Matrix Requirements GmbH
• Aaron Joseph, Principal Consultant at Sunstone Pilot, Inc.
• Wolfgang Huber, co-founder at Matrix Requirements GmbH

View slides here

Additional Resources

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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