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Glossary Term
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ISO 62304 (Medical Device Software – Software Life Cycle Processes)

Definition

ISO 62304 is an international standard that defines the requirements for the life cycle of medical device software. It ensures that software is developed and maintained in a way that prioritizes safety, reliability, and compliance with regulatory requirements. The standard applies to standalone medical device software and software integrated into medical devices.

Relevance to the MedTech Industry

ISO 62304 provides a structured approach to managing software development and maintenance, ensuring that medical device software meets safety and performance expectations. This standard is critical for reducing risks associated with software errors and ensuring compliance with global regulations.

Additional Information & Related Terms

Key Components of ISO 62304

  1. Software Development Process

    • Covers planning, implementation, verification, and integration of medical device software.

  2. Software Risk Management

    • Requires integration with ISO 14971 for identifying, evaluating, and mitigating risks associated with software.

  3. Software Maintenance Process

    • Provides guidelines for updating, modifying, or decommissioning software while maintaining safety and compliance.

  4. Problem Resolution Process

    • Outlines requirements for identifying, tracking, and resolving software issues that arise during development or post-market use.

  5. Software Classification

    • Categorizes software safety levels (Class A, B, or C) based on the potential impact of software failure:

      • Class A: No injury or damage possible.

      • Class B: Potential non-serious injury.

      • Class C: Potential serious injury or death.


Examples of Applications

  • Embedded Software: Operating systems and control systems within infusion pumps or imaging devices.

  • Standalone Software: Mobile health (mHealth) apps or clinical decision support systems (CDSS).

  • Wearable Devices: Software for monitoring and transmitting physiological data.

  • Artificial Intelligence (AI) in Medicine: Machine learning algorithms for diagnostic or therapeutic purposes.

Related Terms

  • Risk Management (ISO 14971): Aligns with ISO 62304 to manage software-related risks.

  • Cybersecurity for Medical Devices: Increasingly integrated with ISO 62304 for secure software development.

  • ISO 13485: The medical device quality management system standard, which includes software quality considerations.

  • Verification and Validation (V&V): A critical component of ISO 62304 for ensuring software safety and performance.

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