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Summary

You must create detailed design specifications that transform your product requirements into implementable solutions, defining the architecture, components, interfaces, and technical details needed to build your medical device. Design activities establish the blueprint that enables manufacturing and verification while ensuring regulatory compliance and patient safety.

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Regulatory Context

Under 21 CFR Part 820.30 (Design Controls), you must implement:
  • Design outputs that meet all design input requirements
  • Documented design specifications enabling manufacturing and verification
  • Design review before proceeding to verification activities
  • Software architecture documentation per IEC 62304 for software devices
  • Risk control implementation integrated into design specifications
Special attention required for:
  • Software as Medical Device architecture and SOUP management
  • Cybersecurity by design implementation per FDA guidance
  • Biocompatibility assessment for patient-contacting materials per ISO 10993
  • Electromagnetic compatibility (EMC) considerations for all electronic devices

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Overview

Design represents the creative transformation of your product requirements into tangible, implementable solutions that define exactly how your medical device will be built, operate, and deliver its intended medical benefits. This comprehensive process bridges the gap between what your device must do and how it will actually accomplish those functions through systematic architecture definition and detailed specification development. Software Architecture establishes the foundational structure for software-containing devices by defining software items, their interconnections, deployment infrastructure, and security frameworks. The architecture must demonstrate systematic organization that supports your device’s safety classification under IEC 62304 while enabling verification activities and ongoing maintenance. Your software design must address scalability, reliability, and cybersecurity from the ground up, incorporating risk control measures as integral features rather than add-on protections. The architecture serves as the blueprint that guides all software development activities and provides the framework for managing Software of Unknown Provenance (SOUP) components safely. SOUP management represents a critical subset of software design that requires systematic identification, assessment, and control of all third-party software components integrated into your device. Each SOUP item must be evaluated for patient safety impact, documented with specific version control, and monitored for security vulnerabilities throughout the device lifecycle. SOUP risk classifications drive verification requirements and ongoing monitoring procedures, ensuring that external dependencies don’t compromise device safety or effectiveness. Interface Design defines how users interact with your device and how different system components communicate with each other. User interfaces must support safe, effective use while minimizing use-related risks identified in your risk assessment. Technical interfaces between hardware and software components require precise specification of communication protocols, data formats, timing requirements, and error handling to ensure reliable operation and maintainability. Hardware design activities encompass mechanical, electrical, firmware, and packaging specifications that transform functional requirements into physical components. Mechanical design must address structural integrity, environmental resistance, and user ergonomics while ensuring manufacturability and serviceability. Electrical design requires consideration of power management, signal integrity, electromagnetic compatibility, and safety isolation. Firmware design bridges hardware and software domains, requiring careful attention to real-time constraints, safety-critical functions, and update mechanisms. Packaging and shelf-life design ensure your device reaches users in safe, effective condition and maintains its performance throughout the intended storage and use periods. Design considerations include environmental protection, sterility maintenance (where applicable), labeling requirements, and degradation prevention mechanisms that support your device’s intended shelf life and operational lifetime. The integrated nature of design activities requires careful coordination between different engineering disciplines to ensure that hardware, software, mechanical, and user interface components work together seamlessly. Design decisions in one area often impact other components, requiring systematic impact assessment and traceability maintenance throughout the design process. Design verification planning begins during design specification by establishing clear criteria for confirming that design outputs meet design inputs. Each design element must include verification methods that can objectively demonstrate compliance with requirements, supporting efficient transition to verification and validation phases. Risk control integration ensures that safety measures identified in your risk management process are built into the design rather than relying on external protections or user training. Design-level risk controls are typically more effective and reliable than protective measures or information for safety, contributing to overall device safety and user confidence. Your design activities must balance innovation with regulatory compliance, creating solutions that meet user needs effectively while adhering to applicable standards and regulations. Well-executed design reduces verification complexity, manufacturing costs, and regulatory approval timelines while establishing the foundation for successful commercial deployment and ongoing maintenance throughout the device lifecycle.