Smithers, a specialist in rubber, plastics and composites testing and a provider of chemical analysis, primary pack and shipment testing for medical devices, has opened a dedicated facility for its medical device testing services in Shawbury.
The new facility expands on existing capabilities and will focus on high-volume routine medical device tests ranging from product development to post-market surveillance, in line with the new compliance requirements related to European legislation for drug delivery devices.
"The new laboratory is our latest investment in support of client demand in the medical device space,” said Sam Sheppard Fidler, vice president and general manager, Smithers Rapra and Smithers Pira Europe.
“The expansion affords more capacity for high-volume testing, enabling us the potential to triple the number of tests we can perform.”
The laboratory team is welcoming customers and prospective clients to visit the new facility and see first-hand how high volume routine medical tests are expedited.
Types of testing that will be handled at the new Shawbury facility include (but are not limited to):
- Leakage
- Ease of assembly
- Actuation assessment
- Simulated use and ease of use
- Dose accuracy
- Tamper evidence assessment
- Verifications of product claims
- Visual inspections
- Dimensions
- Connection compatibility
Leading the team in the new lab is Chris Berry, Ph.D., manager, medical device physical testing. Dr. Berry has worked for Smithers for nine years and served previously as principal scientist at the Smithers Pira Packaging and Technical Services laboratory located in Leatherhead.
As testing volume increases, Berry plans to bring additional employees on board over the course of the next 12-18 months.
