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Newsletter V. 2019 Issue 1

Embracing Change: Your Connected Medical Device is Never Finished Embracing change means setting up your organization, processes, and tools to efficiently manage changes during product development and after product launch. Agile Design Controls: Dynamic Risk Management for SW-Intensive Medical Devices Learn the nuts and bolts of how to integrate risk management into the overall product […]

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AgileDesignControlWebinar1903

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

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ADC-Webinar201902

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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Connected Devices Summit

Connected Devices: Cybersecurity & Compliance Summit

Is your medical device secure? I learned a lot about the latest trends in cybersecurity and how to protect medical devices and hospitals at a conference this week hosted in San Francisco and featuring presentations by cybersecurity experts from the medical device industry, from hospital systems, and from vendors of security tools. Medical device cybersecurity 

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Top 10

Top 10 V&V Fails: Don’t Let These Common Mistakes Derail Your Verification and Validation Program

The successful market introduction of a medical device requires design verification and validation testing (V&V) (per 21 CFR 820.30 and ISO 13485 7.3). Even for experienced teams, V&V can be very challenging, requiring tight coordination of multiple activities and the correct execution of many preceding activities. I have worked on V&V testing for a wide

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