Our independent experts have extensive experience supporting clients with medical device verification testing and processes.

We provide a wide range of standard medical device testing and also develop and validate bespoke tests used to support regulatory submissions in the EU and US.

Our experts provide support for

  • Medical device and product development
  • Demonstrating conformance to industry standards
  • Evaluating functional performance against specific design requirements
  • Independent production batch conformance testing and post market surveillance
Our experts provide guidance and support throughout the medical device testing process ensuring clients have confidence in their product and its eventual use. 

Product testing capabilities include

  • Ease of assembly
  • Actuation assessment
  • Simulated use and ease of use
  • Dose accuracy
  • Tamper evidence assessment
Find out more about specific test capabilities
  • Test method design and validation
  • Verifications of product claims
  • Visual inspections
  • Dimensions
  • Connection compatibility
 

Products tested include

  • Metered dose inhalers (MDIs)
  • Needle-based injection systems (NISs)
  • Hypodermic syringes and prefilled syringes
  • Packaging for terminally sterilised MDTs
  • Pump dispensers
  • Small bore connectors
  • Transfusion equipment
  • Injection vials and caps
  • Small bore connectors
  • Contraceptive products tested to ISO 8009 and ASTM D6976-13
 

Testing for specific medical devices

Find out more about testing we provide for specific devices including syringes and other injectables.

Download a brochure for more information:

Physical and Functional Testing of Medical Devices
Smithers-Drug-Delivery-Device-and-Accessories-Testing

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