Medical Devices and Components

We provide expert support to help clients prove compliance to a range of international standards, including FDA, MHRA, USP, ASTM and ISO. Our experts have a wealth of experience in medical device, materials, and packaging testing, and provide analytical support across the medical device supply chain.

We test a wide range of medical devices - and their components - including: 

  • Syringes
  • Prefilled Syringes
  • Small Bore Connectors
  • Smart Patches / Patch Pumps
  • Hypodermic Needles
  • Pen, Jet and Auto Injectors
  • Medical Aerosol Devices

Standard and Non-Standard Testing Programmes

Our expert team provide standard testing to fulfil a range of international testing standards, and can provide consultative support to help you demonstrate that your product complies with regulatory demands. 

We also develop bespoke test methods to enable clients to assess properties which might not otherwise be evaluated within the boundaries of standard testing. This is accompanied by a rigorous method validation process, verifying to clients that our custom test methods are reliable and repeatable. 

We offer a full range of medical device testing services:

  • Material testing, characterisation and selection
  • Custom test method development and validation
  • Extractables and leachables assessments
  • Individual and batch device testing 
  • Shelf life studies
  • Transit and distribution testing
  • Secondary packaging - durability testing and sterility assurance
  • Anti-counterfeiting assessments
  • Product durability testing
  • Technical investigations and failure analysis

Some of these testing procedures are undertaken by our sister company Smithers Rapra. 

Smithers Rapra >

Standards and Accreditation

Our expert teams work to our high quality standards. Our laboratories are UKAS accredited to ISO 17025, and we can undertake activities with GMP compliance if required.

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