Ensuring Quality - The Key Elements of Technical Documentation for Medical Devices

ImFusion provides advanced medical imaging software tailored for integration into certified medical devices. We not only develop state-of-the-art software but also supply the comprehensive technical documentation essential for regulatory compliance, tailored to each project's needs, whether for custom software per IEC 62304 standards or validating existing components as SOUP. This white paper outlines ImFusion's process for developing and documenting software for medical devices, highlighting our dedication to innovation and regulatory adherence.

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Getting the Green Light - Regulatory Framework for Software as a Medical Device

Medical devices have evolved significantly, with software now playing a crucial role, including the rise of stand-alone software medical devices. This white paper explores the regulatory environment for medical devices, highlighting the EU and FDA processes and the specific challenges software medical devices face, such as cybersecurity and data privacy. With the regulatory landscape continuously adapting to technological changes, manufacturers must keep up with evolving standards to ensure their products are safe, effective, and innovative. ImFusion offers expertise in developing medical software to IEC 62304 standards and providing comprehensive technical documentation, ensuring our solutions meet the highest quality and regulatory standards.

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