October 23rd, 2024 by Audrey Marcum
compliance partner software development
In our recent two-part webinar series, hosted by our partner Vladimir Plotkin at Imarsys, we uncovered the keys to mastering IEC62304 compliance for medical device software and how this applies in SpiraPlan. If you're navigating the complex world of regulatory standards, this series is essential viewing. Dive into the highlights below to see why meeting IEC62304 requirements is critical to your success, and don't miss the chance to watch the full sessions!
Recording Part 1
Recording Part 2
Key Takeaways
Understanding and complying with IEC62304 is crucial for any company developing software for medical devices. This industry standard ensures that your software meets strict safety, quality, and regulatory requirements, making it indispensable for global market approval. The webinars highlighted both the theoretical principles and practical application of IEC62304 to streamline your compliance efforts.
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IEC62304 Essentials: We covered the core principles of IEC62304, the international standard for the Software Development Life Cycle (SDLC) of medical devices, highlighting its significance in achieving regulatory approval globally.
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Why Compliance Matters: Compliance isn't optional—it's the gateway to selling your medical device software in regulated markets like the U.S. (FDA) and Europe. Understanding this ensures your software meets safety and quality expectations.
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Practical Implementation with SpiraPlan: Vladimir demonstrated how to apply IEC62304 in SpiraPlan (part 2), showing how to organize medical device projects, map components, and maintain traceability from requirements to testing.
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Live Demo and Expert Guidance: The live demo walked through real-world use cases of SpiraPlan, making the process of IEC62304 compliance manageable.
If you'd like to learn more about this industry standard and its application in SpiraPlan, feel free to contact Vladimir Plotkin at Imarsys for more information. You can also inquire about receiving a copy of the webinar slide decks for further insights.