Invibio™ Biomaterial Solutions Receives ISO 17025:2005 Accreditation from UKAS
Invibio™ Biomaterial Solutions (“Invibio”), a world-leading solutions provider of PEEK polymer-based biomaterials, manufacturing and R&D for medical device manufacturers, has announced that its laboratories have been accredited to ISO 17025:2005 by UKAS (United Kingdom Accreditation Service). 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.
Accreditation to ISO 17025:2005 reinforces Invibio’s position as a pioneering, reliable R&D partner that consistently invests in knowledge and technologies to bring superior products and components to medical device manufacturers. Until Invibio received this accreditation, material properties testing was conducted at ISO-17025 accredited third-party test laboratories. This new accreditation by UKAS means that test data for the accredited standards generated by Invibio’s laboratories are validated as being precise and accurate. This minimizes Invibio’s reliance on third-party testing laboratories and gives customers confidence that the polymer products they receive meet the rigorous testing and calibration standards established in the ISO 17025:2005 standards.
Material processes and products meet highest standards
“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. “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.”
Specifically, the ISO 17025:2005 accreditation schedule covers the following test procedures on the part of Invibio:
► Tensile Testing to ISO 527-1:2012 and ISO 527-2:2012
► Flexural Testing to ISO 178:2010+A1:2013
► Determination of Density by Immersion to ISO 1183-1:2012
► DSC (Differential Scanning Calorimetry) Analysis (ISO 11357-1:2009) for the determination of Glass Transition, Tg, (ISO 11357-2:2013), Crystallization Point, Tc, and Melting Point, Tm, (ISO 11357-3:2011).
“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.”
Invibio™, a Victrex plc company, has grown significantly since pioneering PEEK biomaterial in 1999, evolving from a materials supplier to an industry-leading provider of biomaterial solutions. During that time the company has worked with world class research institutions, to develop and commercialize 6 implantable PEEK grades. Today, Invibio’s PEEK-OPTIMA™ polymers are used in more than four million implanted devices worldwide.