Get Expert Support to Understand Key Connections in ISO 13485

ISO 13485 specifies the requirements for a quality management system (QMS) for medical device manufacturers, which includes regulatory and safety compliance requirements. IEC 62304 is closely linked to ISO 13485 in several ways:

1. Risk Management: ISO 13485 requires that risk management be a part of the entire lifecycle of medical devices, from design to production and post-market. IEC 62304 integrates risk management into the software development lifecycle, ensuring that software development processes identify and mitigate risks to safety.

2. Document Control and Traceability: Both standards emphasize the importance of traceability, documentation, and record-keeping. ISO 13485 requires documentation of all processes related to product development, while IEC 62304 specifies the need for detailed records on software development activities, risk analysis, and testing results.

3. Design and Development: ISO 13485 mandates that the design and development process for medical devices (including software) be controlled, including planning, design verification, and validation. IEC 62304 provides a detailed framework for managing the software aspect of this process, including the required development and maintenance activities.

4. Post-Market Surveillance: ISO 13485 requires that manufacturers monitor the performance of the device once it is on the market, including any software issues that arise. IEC 62304 includes provisions for ongoing software maintenance and handling software changes, which aligns with ISO 13485’s post-market requirements.

5. Supplier Management: Both standards require the management of external suppliers, particularly those involved in software components. ISO 13485 emphasizes the need to assess supplier compliance with quality standards, and IEC 62304 ensures that any software components integrated into a medical device meet the necessary safety and regulatory requirements.

Summary of Key Connections:

• Document Control: Both standards stress the importance of maintaining records and traceability throughout the software lifecycle.

• Risk Management: Risk assessment and mitigation are integral to both standards, with IEC 62304 incorporating safety-critical evaluations throughout the software development process.

• Verification and Validation: ISO 13485 requires validation at various stages, and IEC 62304 prescribes rigorous testing and verification of software to meet these regulatory demands.

• Post-Market Activities: Ongoing software updates, issue resolution, and feedback are part of both IEC 62304 and ISO 13485, ensuring that safety is maintained throughout the product’s lifecycle.

Together, IEC 62304 and ISO 13485 create a comprehensive framework for ensuring that software for medical devices is developed, tested, and maintained to the highest standards of quality, safety, and compliance.