Smithers extends accreditation scope for medical device testing

By Melissa Fassbender

- Last updated on GMT

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

Related news

Show more

Related products

show more

Powered by Ingredients + Innovation

Powered by Ingredients + Innovation

Content provided by Univar Solutions USA | 07-Oct-2024 | Product Brochure

In partnership with our industry-leading supplier partners, Univar Solutions Pharmaceutical Ingredients is proud to introduce Powering Healthy Tomorrows.

Reliability, scale, and security of supply

Reliability, scale, and security of supply

Content provided by Univar Solutions USA | 28-Aug-2024 | Product Brochure

Univar Solutions Pharmaceutical Ingredients is proud to offer one of the most expansive portfolios of 15,000+ products, including high-purity solvents,...

Increasing the Bioavailability of Oncology Drugs

Increasing the Bioavailability of Oncology Drugs

Content provided by Lonza Small Molecules | 13-Nov-2023 | White Paper

Oral tyrosine kinase inhibitors (TKIs) are a class of cancer drugs that can be highly susceptible to issues with solubility in the gastrointestinal tract

Addressing Challenges with Clinical In-Use Testing

Addressing Challenges with Clinical In-Use Testing

Content provided by Lonza | 12-Oct-2023 | White Paper

Lonza Drug Product expert Léa Sorret PhD explores Clinical In-Use Testing of Biotherapeutics in this white paper. Léa shares her expertise and describes...

Related suppliers

Follow us

Products

View more

Webinars