Smithers extends accreditation scope for medical device testing

By Melissa Fassbender

- Last updated on GMT

(Image: iStock/Ca-ssis)
(Image: iStock/Ca-ssis)

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Testing services provider Smithers Pira has extended its ISO/IEC 17025:2005 scope of accreditation for medical devices.

Smithers Pira, one of six companies that make up The Smithers Group, provides market intelligence and testing services at facilities in the UK and US.

The United Kingdom Accreditation Service (UKAS) accreditation covers the company’s dedicated medical device testing facility in Shawbury, UK, which was opened in December 2016.

According to the company, accreditation by UKAS to ISO/IEC 17025:2005 recognizes Smithers “competence, impartiality, and reliability in its ability to deliver results​.”

The extended UKAS scope of accreditation covers vials, prefilled syringes, needle-based injection systems, and syringes.

Good Manufacturing Practices

Smither Pira also announced that the Shawbury facility is compliant with current Good Manufacturing Practices (cGMP) in April of this year.

Patient safety is a critical concern for all medical and pharmaceutical manufacturers, which is why the quality of the supply chain – including testing services – is so important​,” said Dr Chris Berry, Manager, Medical Device Physical Testing, Smithers Pira, in a press release.

cGMP services available at the facility include design verification testing, stability studies, batch release, and post market surveillance

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