Have employees new to medical devices? I offer practical training on Medical Device Design Controls either on site or at a public workshop. Contact me 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 [...]
https://vimeo.com/326954860 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 [...]
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. Why connected devices are different? Agile Design Controls: Dynamic Risk Management for SW-Intensive Medical Devices Learn the nuts and bolts [...]
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 [...]
https://vimeo.com/317634638 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 [...]
FDA Software Guidances and the IEC 62304 Software Standard There are two sets of rules for SW regulation—twice the rules, twice the confusion. My recommendation is to base your software development procedures on the IEC 62304 Standard and then include any additional adjustments needed to meet all the FDA requirements. [...]
https://youtu.be/1mU2qo7GuT0 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 [...]
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