Regulatory Compliance

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Everything You Need to Know About IEC 62304 Compliance for Medical Devices

Regulatory Compliance / By Thushan Wickramasinghe

Medical device software development is evolving rapidly—but are you meeting compliance standards? IEC 62304 is the gold standard for ensuring the safety, security, and reliability of medical device software. With the rise of AI-driven diagnostics, remote patient monitoring, and connected healthcare, compliance with IEC 62304 is now more crucial than ever. What is IEC 62304? …

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A Beginner’s Guide to FDA Compliance for Medical Device Software

Regulatory Compliance / By Thushan Wickramasinghe

Navigating FDA compliance for medical device software can be overwhelming. With stringent regulations and evolving standards, it’s vital to have a clear roadmap to ensure safety, quality, and market approval. At Critical Software Solutions (CSS), we specialize in simplifying this process, helping businesses adhere to FDA requirements while maintaining exceptional standards. In this guide, we’ll …

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