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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.

  1. Establish and document design and development planning procedures
  2. Implement comprehensive design input requirements development process
  3. Create design verification and validation procedures including test methods
  4. Establish formal design review process with multi-disciplinary team
  5. Develop design transfer procedures to translate design into production specifications
  6. Implement design change control procedures
  7. Create and maintain Design History File system
  8. Establish risk management process integrated with design controls
  9. Develop procedures for design documentation and record keeping
  10. 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

  • 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

  • Design Controls for Medical Device Manufacturers
  • HTML / PDF
  • Issue date: 1997-03-11
  • Last changed date: 2020-03-18
  • Status: FINAL
  • Official FDA topics: Medical Devices, Good Clinical Practice (GCP)
  • ReguVirta summary file ID: 0d595673e5fd545acd4bf8d48025b2d5
This post is licensed under CC BY 4.0 by the author.