SMITHERS

Smithers helps medical device and pharmaceutical product manufacturers bring innovative and highly effective products to market with world-class expertise and extensive, independent testing capabilities at accredited facilities in the UK and USA.

Our experienced team will provide advice, guidance and recommendations as well as delivering test data to help you demonstrate compliance to regulatory guidance or specifications set out by the FDA, cFDA, EMA, MHRA, USP, ASTM and ISO.

We can assist throughout your medical device product development.

Services include:

• Extractables and leachables studies
• Device physical and functional testing
• Device verification and validation
• Product and packaging durability, integrity and stability testing
• Material selection, property characterization, life prediction
• Failure analysis