Medical Device Testing

Smithers Medical Device Testing helps medical device and pharmaceutical product manufacturers bring innovative, compliant and highly effective products to market with our world-class expertise and extensive independent medical device testing capabilities.

We can assist throughout your medical device product development cycle, with medical device testing from concept, material selection, design for manufacture, manufacture, packaging (primary and secondary) through to the distribution testing for supply chain validation. 

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, EMA, MHRA, USP, ASTM and ISO.

Our global conferences and market reports provide an independent and expert view of emerging markets, technologies and disruptive factors. We also offer bespoke consultancy services, helping companies solve specific business issues and assisting with strategic business planning.

Testing by Product

Testing by Product

Smithers Medical Device Testing helps medical device and pharmaceutical product manufacturers bring innovative and highly effective products to market with our world-class expertise and extensive independent testing capabilities.

Physical and Functional Testing of Medical Drug Delivery Devices

Physical and Functional Testing of Medical Drug Delivery Devices

Smithers Medical Device Testing provides standard and non-standard medical device testing (ISO, ASTM or Pharmacopeia) on a wide range of drug delivery devices, accessories and packaging to ensure products are compliant and fit for use.

Chemical Analysis

Chemical Analysis

Smithers Medical Device Testing supports the pharmaceutical and medical device industry with expert advice, troubleshooting and testing services within our FDA registered and inspected laboratories in the UK and USA.

Healthcare Packaging Testing

Healthcare Packaging Testing

Smithers provides a range of packaging services to ensure that medical products are packed in such a way that their characteristics and performance during intended use will not be adversely affected during transport and storage.

Medical Device Technical Consulting

Medical Device Technical Consulting

Smithers Medical Device Testing world-class technical team will help you solve problems and optimise your materials, device and packaging. 

Medical Device Regulation (MDR)

Medical Device Regulation (MDR)

Smithers Medical Device Testing provides comprehensive services to the pharmaceutical, biopharmaceutical and medical device industries in support of the new Medical Device Regulations (MDR).

ISO 13485:2016 Certification System

ISO 13485:2016 Certification System

Smithers offers ISO 13485 certification services to medical device manufacturers who are looking to realize or establish consistent supplier quality, clear best practices for design, and efficient manufacturing and distribution programs.