Design Verification Testing (DVT) for Combination Products

Design Verification Testing (DVT) for Combination Products

Updated July 2025

Design Verification Testing (DVT) is part of the design and development process for medical devices and is included in standards like ISO 11040, ISO 11608, & ISO 80369. DVT is performed to ensure that a product’s design meets the specified design requirements, including testing for devices such as prefilled syringes, autoinjectors, infusion pumps, pen injectors, on-body delivery systems, and metered dose inhalers. In short, DVT aims to confirm that the design outputs of the medical device, such as dimensional specifications, performance characteristics, and other features are documented, and comply with the design inputs and intended purpose.

This Resource Covers:

  • The role of DVT in product development and regulatory review
  • Core DVT activities, including performance, dimensional, and functional testing
  • Design verification for complex combination products, such as:
    • Prefilled syringes
    • Pen Injectors
    • Autoinjectors
    • On-Body Delivery Systems
    • Infusion Pumps
    • Metered Dose Inhalers
  • Standards commonly referenced during DVT, including ISO 11608, ISO 11040-8, and IEC 60601-2-24
  • Additional support services, such as early-phase R&D, engineering validation testing (EVT), and reference product comparison

Download the overview below: 

Smithers-Design-Verification-Testing-2025
Smithers-Design-Verification-Testing-2025
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