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Summary

You must conduct systematic design reviews using structured checklists to verify that your medical device design is complete, compliant, and ready for verification and validation activities. Design stage checklists provide objective criteria to confirm that all design inputs are properly implemented and regulatory requirements are met before proceeding to testing phases.

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Regulatory Context

Under 21 CFR Part 820.30(e) (Design Controls), you must implement:
  • Mandatory design review conducted by qualified individuals not directly responsible for design
  • Documented evidence that design outputs meet design inputs and user needs
  • Systematic evaluation of design completeness before verification activities
  • Objective criteria for determining design readiness and regulatory compliance
  • Review records maintained as evidence of design control execution
Special attention required for:
  • Software medical devices requiring IEC 62304 compliance verification
  • Risk management integration confirmation per ISO 14971 standards
  • Cybersecurity design validation per FDA cybersecurity guidance
  • Design input validation against user needs and intended use requirements

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Overview

Design stage checklists serve as critical quality gates that systematically verify your medical device design is complete, compliant, and ready for the verification and validation phases that follow. These structured evaluations prevent costly rework by identifying missing requirements, incomplete designs, or regulatory compliance gaps before you invest significant resources in testing and validation activities. Design Review Checklists provide comprehensive evaluation frameworks that examine your design from multiple perspectives to ensure regulatory compliance and development readiness. The review process requires systematic examination of design completeness, requirement implementation, and regulatory alignment using objective criteria that eliminate subjective decision-making. These checklists transform abstract design control requirements into concrete evaluation steps that provide clear evidence of compliance for regulatory submissions. General design review focuses on fundamental design control requirements by verifying that user needs are properly translated into design inputs and that design outputs adequately address all specified requirements. The review confirms that your development process maintains proper traceability from user needs through design implementation, ensuring that every aspect of your device’s intended functionality is deliberately planned and implemented. Critical elements include verification that risk control measures from your risk management process are integrated into the design rather than relying solely on protective measures or user information. Software architecture review addresses the specialized requirements for software-containing medical devices by confirming compliance with IEC 62304 software lifecycle processes. The review verifies that your software architecture implements all system and software requirements with appropriate safety classification and that all software items and interfaces are properly documented. For devices containing Software of Unknown Provenance (SOUP), the review confirms that third-party components are properly integrated, assessed, and controlled according to regulatory requirements. Physical product review evaluates hardware components to ensure that design specifications support manufacturing, assembly, and testing requirements. The review confirms that material selection meets biocompatibility and durability requirements, that design addresses environmental and safety factors comprehensively, and that packaging and shelf-life considerations support the intended product lifecycle. Even primarily software-based devices often require physical product considerations for deployment hardware and user interaction components. Regulatory compliance verification ensures that your design addresses all applicable standards and regulations before proceeding to verification activities. The review confirms that design inputs align with regulatory requirements, that applicable standards are properly implemented, and that design outputs provide sufficient specification detail to enable comprehensive verification and validation testing. Risk control implementation represents a critical aspect of design review that verifies safety measures identified in your risk management process are properly integrated into design specifications. The review confirms that hazards are controlled through design features rather than relying primarily on protective equipment or user training, which provides more reliable and effective risk mitigation. Documentation completeness assessment ensures that your design specifications provide sufficient detail to enable manufacturing, testing, and regulatory review. The review verifies that design documents include all necessary technical specifications, interface definitions, performance criteria, and verification requirements needed for successful product development and regulatory approval. Resource and timeline validation confirms that your design can be implemented with available resources, technical capabilities, and schedule constraints. The review identifies potential implementation challenges early, enabling proactive risk mitigation and realistic project planning for subsequent development phases. The systematic nature of design stage checklists provides objective evidence that your design process was thorough and compliant, supporting regulatory submissions and demonstrating due diligence in device safety and effectiveness considerations. Well-executed design reviews reduce verification complexity, prevent late-stage design changes, and increase confidence in regulatory approval success by ensuring that fundamental design issues are resolved before testing begins.