Medical Device and Packaging Testing

As a UKAS ISO 17025 accredited laboratory, we perform both standard and non-standard tests on a range of medical devices, accessories and packaging, to ensure that they are safe and fit for purpose.

Smithers Pira has comprehensive experience supporting clients with characterisation and verification tests as well as developing and validating bespoke tests, which are subsequently used to provide evidence for regulatory submissions. Our experts provide guidance and support throughout the process ensuring clients have confidence in their product and its eventual use.

Testing can be performed as part of product development testing or to show conformance with appropriate standard requirements and/or demonstrate that the functional performance of the product satisfies specific design requirements.

Devices and accessories tested include:
  • Metered dose inhalers  (MDIs)
  • Needle-base injection systems (NISs)
  • Pump dispensers
  • Syringes
  • Prefilled syringes
  • Small bore connectors for liquids and gases
  • Transfusion and  IV sets

 

Product testing services:
  • Ease of assembly
  • Actuation assessment
  • Simulated use and ease of use
  • Dose accuracy
  • Tamper evidence assessment
  • Test method design and validation
  • Verifications of product claims
  • Visual inspections
  • Dimensions
  • Connection compatibility
Packaging testing services:
  • ISO 11607 package validation testing
  • Integrity testing
  • Seal strength testing
  • Sterile barrier system testing
  • Shelf life studies
  • Transport simulation

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