UK product testing group Smithers has announced an extension to its ISO/IEC 17025:2005 scope of accreditation for medical devices.
The United Kingdom Accreditation Service (UKAS) accreditation covers Smithers dedicated facility for medical device testing at Shawbury, UK for a range of commonly performed tests. Accreditation by UKAS to ISO/IEC 17025:2005 officially recognises Smithers competence, impartiality and reliability in its ability to deliver results.
With the tests for vials, prefilled syringes, needle-based injection systems and syringes accredited, Smithers can apply the UKAS and International Laboratory Accreditation Cooperation (ILAC) stamp to reports which cover testing performed to these standards.
The tests are core components of Smithers’ testing programme in its Shawbury facility, where it offers a broad range of medical device testing services.
Chris Berry, manager of medical device testing at Smithers, said: “Updating our accredited scope demonstrates our commitment to quality assurance and our willingness to comply with client requests”.
The facility opened in December 2016 expands on existing capabilities and focuses 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.
