Design Verification (DV) Testing Services

Medical device testing for regulatory submission

DV testing is part of the design and development process used to demonstrate that design outputs match design inputs and must be considered for all medical devices. Test methods are typically in accordance with applicable international standards. However, depending on device classification, novelty, intended usage, and risk level, custom-developed test methods may be required.

STERIS offers a wide range of standardized test methods:

  • ISO 10555-1 (sterile and single use catheters)
  • ISO 7886-1 (sterile and single use syringes)
  • ISO 11608-1 (needle-based injection systems)
  • ISO 11040-4 / ISO 11040-5 (prefilled syringes)

Test types include:

  • Dimensional analysis
  • Simulated use testing
  • Mechanical strength
  • Torque strength
  • Material and device characterization
  • Burst pressure / leak assessments
  • Environmental
  • Shock
  • Vibration

Device types include:

  • Catheters
  • Delivery systems
  • Guidewires
  • Auto-injectors
  • Pre-filled syringes and needles
  • Inhalers
  • Insulin pumps
  • Ventilators
  • Endoscopic

Technical Support

STERIS also offers support, including:

  • Early-stage design
  • Risk assessment
  • Identification of applicable test standards
  • Test method development and validation
  • Protocol development
  • Test planning and project management
  • Technical file documentation

STERIS also offers packaging testing and comprehensive packaging validations: Contact Us

Contact our team of experts to find out more about our Global Contract Sterilization Services