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.
What You Need to Know? 👇
What are design controls and why are they important for medical device manufacturers?
Design controls are an interrelated set of practices and procedures incorporated into the design and development process, creating a system of checks and balances. They make systematic assessment integral to development, helping identify deficiencies early when corrections are less costly and more effective.
Which medical devices are subject to FDA design control requirements?
All Class III and Class II medical devices must comply with design controls. Additionally, specific Class I devices are subject to these requirements, including devices with computer software and certain listed devices like tracheobronchial suction catheters and surgeon’s gloves.
How do design verification and design validation differ in practice?
Design verification confirms that design output meets design input requirements through testing, inspection, or analysis. Design validation ensures the device meets user needs and intended uses under actual or simulated conditions, typically using production units rather than prototypes.
What should be included in design input requirements for medical devices?
Design input requirements must be comprehensive, covering functional requirements (what the device does), performance requirements (how well it performs), and interface requirements (compatibility with external systems). They should be unambiguous, quantitative with tolerances, and address the intended use environment.
When should formal design reviews be conducted during development?
Formal design reviews should be planned at strategic points, typically at the end of each development phase and at important milestones. For complex devices, multiple reviews may be needed, while simple designs might require only one review at conclusion.
What documentation must be maintained in the Design History File (DHF)?
The DHF must contain or reference records demonstrating the design was developed according to the approved plan and regulatory requirements. This includes design plans, input/output documents, review records, verification/validation results, and change control documentation for each device type.
What You Need to Do 👇
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