IEC 62304 Compliance Guide: Ensuring Medical Device Software Safety

Navigating the Critical Standard for Medical Software Development

Medical device software failures represent a significant proportion of adverse events and recalls—often with serious consequences for patient safety. IEC 62304, the international standard governing medical software lifecycle processes, provides the critical framework for developing and maintaining safe, effective software solutions.

Our comprehensive 31-page analysis examines:

  • Core Processes and Requirements: Detailed breakdown of the five essential IEC 62304 processes—development, maintenance, risk management, configuration management, and problem resolution

  • Safety Classification Framework: Clear guidance on defining software Classes A, B, and C based on potential harm, with impact on required documentation and process rigor

  • Real-World Impact: Analysis of software-related medical device failures reported to the FDA MAUDE database

  • Common Compliance Pitfalls: Identification of frequent challenges organizations face when implementing IEC 62304 requirements

  • Practical Recommendations: Actionable strategies to enhance compliance and improve medical device software safety

Whether you're new to medical device development or looking to strengthen your existing processes, this resource provides valuable insights to navigate IEC 62304 compliance efficiently and effectively.

Get your copy of our IEC 62304 Analysis.

Why Understanding IEC 62304 Matters

As a harmonized standard recognized by major regulatory authorities worldwide, IEC 62304 compliance is effectively mandatory for market access in the US, EU, and other key regions. Beyond regulatory necessity, properly implementing the standard's risk-based approach is essential for:

  • Reducing software-related adverse events and recalls

  • Strengthening your quality management system

  • Streamlining development processes

  • Enhancing team collaboration

  • Creating safer products for patients

At Product Creation Studio, we've guided numerous medical device manufacturers through the complexities of software development and regulatory compliance. This resource distills our experience into practical guidance for your organization.

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