Design Controls for Medical Device Manufacturers
This guidance is intended to assist medical device manufacturers in understanding and implementing design controls as part of their quality system. It applies to the design of medical devices and associated manufacturing processes, covering both new designs and modifications to existing device designs. The guidance aligns with FDA's Quality System regulation and ISO standards.
Recommended Actions
- Establish and document design and development planning procedures
- Implement comprehensive design input requirements development process
- Create design verification and validation procedures including test methods
- Establish formal design review process with multi-disciplinary team
- Develop design transfer procedures to translate design into production specifications
- Implement design change control procedures
- Create and maintain Design History File system
- Establish risk management process integrated with design controls
- Develop procedures for design documentation and record keeping
- Train personnel on design control procedures and requirements
Key Considerations
Non-clinical testing
- Design verification must confirm design output meets design input requirements through tests, inspections and analyses
- Verification activities should be conducted at all stages and levels of device design
- Results must be documented in Design History File
Human Factors
- Design validation must ensure devices conform to defined user needs and intended uses
- Testing should be performed under actual or simulated use conditions
- Particular care needed to distinguish between customers, users and patients needs
Software
- Software validation required where appropriate as part of design validation
- Software source code should be maintained in Design History File
Labelling
- Product packaging and labeling must be validated
- Labeling specifications must be included in production specifications
Biocompatibility
- Biocompatibility testing of materials required as part of design verification where applicable
- Bioburden testing required for products to be sterilized
Safety
- Risk analysis required where appropriate as part of design validation
- Risk management should be integrated into design process
- Safety requirements must be explicitly stated in design inputs
Other considerations
- Design controls must be documented in Design History File
- Design changes must be identified, documented, validated/verified, reviewed and approved before implementation
- Production specifications must ensure manufactured devices are repeatedly and reliably produced
- Design transfer procedures needed to translate design into production specifications
- Design reviews required with multi-disciplinary team including independent reviewer
Relevant Guidances
- Software Validation for Medical Device Production, Quality Systems, and Device Components
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Content of Premarket Submissions for Device Software Functions
- Recommended Format and Content for Non-Clinical Bench Performance Testing in Medical Device Premarket Submissions
Related references and norms
- ISO 9001:1994: Quality Systems Model for Quality Assurance in Design, Development, Production, Installation, and Servicing
- ISO/DIS 13485: Quality Systems Medical Devices Particular Requirements for the Application of ISO 9001
Original guidance
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