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Home/Company News/Invibio Labs Accredited in the UK
Company News

Invibio Labs Accredited in the UK

September 10, 2014 1 min read Premium comments

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Invibio Labs Accredited in the UK
IGTC Granule Inspection Lowres / Source: Invibio Biomaterial Solutions
Secondary

Confidence building…Invibio Biomaterial Solutions is announcing that its laboratories have been accredited to ISO 17025:2005 by UKAS (United Kingdom Accreditation Service). As noted in the September 2, 2014 news release, “this achievement demonstrates that Invibio’s Laboratories can consistently produce valid test results for each of the standards for which they have been accredited, averting the need to validate results through third-party laboratories.”

This stamp of approval, says the company, “means that test data for the accredited standards generated by Invibio’s laboratories are validated as being precise and accurate.” Going forward, Invibio’s will need to rely less on third-party testing laboratories.

“For years, Invibio’s PEEK-OPTIMA polymers have been the preferred materials of choice for spinal interbody fusion devices” noted Keith Cartwright, Quality & Regulatory Leader, Medical & Regulatory Compliance at Invibio, in the news release. “Accreditation to ISO 17025:2005 reassures them that our polymers and the processes under which they are tested and validated meet the highest international standards. This accreditation underlines our dedication to continually improving our quality assurance procedures in both production and testing.”

“This successful accreditation to ISO 17025:2005 not only demonstrates our unremitting pursuit of quality, it also means we can further streamline our material properties testing operations and move new products to market faster, ” commented Craig Valentine, Regulatory Affairs Director, Medical & Regulatory Compliance at Invibio. “By not having to rely on third-party test laboratories, we will be saving time and speeding time-to-revenue for our customers as well as ourselves.”

Keith Cartwright told OTW, “Before our lab obtained this accreditation, third party laboratories were used to verify that Invibio PEEK-OPTIMA polymers met test specifications, which could add weeks to the production cycle of PEEK-OPTIMA shapes and components. Now that Invibio is accredited to perform these tests, we eliminate the time and costs associated with sending our products out for external testing, minimizing the time it takes to get these products from the manufacturing line to the supply shelf. Now, some of our customers are evaluating how they might be able to consolidate their supply chain by shifting third-party testing that they were performing independently to Invibio.”

React:

Discussion

14
DS
Dr. Sarah MitchellOrthopedic Surgeon · Mayo Clinic

This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?

8
JT
James Thornton, MDSpine Fellow · HSS

Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.

5
RP
R. PatelSports Medicine · Stanford

We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.

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