How to Tackle Software Regulatory Compliance for Medical Devices

Presented by

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

About this talk

What if you could streamline the delivery of life-saving medical devices? Developing safety- and security-critical software isn't easy. There's no doubt about it. But there's a way to overcome the challenges. Learn how to accelerate the delivery of software compliance to IEC 62304 and other FDA regulations like 510K for medical devices. Join our 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. Key Takeaways * 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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