How to Tackle Software Regulatory Compliance for Medical Devices

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Presented by

Arthur Hicken, Chief Evangelist & Ricardo Camaho, Sr. Technical Marketing Manager

About this talk

Developing safety-and security-critical software isn't easy, especially for life-saving medical devices. Not to mention the challenge of ensuring your software is compliant for IEC 62304 and other FDA regulations like 510K for medical devices. Join this discussion to discover how to cut the cost of achieving certification for Class I, II, and III devices by automating multiple testing methods required by the standard to save time and effort. We'll discuss: • Exploring the IEC 62304 standard and related secure coding standards. • Using static analysis, unit testing, code coverage for medical devices. • Incorporating regulatory safety & security requirements into the SDLC.

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