09.15.14
Invibio Biomaterials Solutions has been granted the ISO 17025:2005, which denotes that the company’s laboratories can 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.
Invibio makes PEEK polymer-based biomaterials and provides manufacturing and research and development for medical device manufacturers of spine, orthopedic, trauma, and certain other specialty devices. The company is based in the United Kingdom with U.S. offices in West Conshohocken, Pa.
“For years, Invibio’s PEEK-Optima polymers have been the preferred materials of choice for spinal interbody fusion devices” said Keith Cartwright, quality & regulatory leader of 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.”
The new ISO specifically covers Invibio’s tensile testing, flexural testing, determination of density by immersions testing, and differential scanning calorimetry analysis processes.
“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,” said Craig Valentine, regulatory affairs director of Medical & Regulatory Compliance. “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 makes PEEK polymer-based biomaterials and provides manufacturing and research and development for medical device manufacturers of spine, orthopedic, trauma, and certain other specialty devices. The company is based in the United Kingdom with U.S. offices in West Conshohocken, Pa.
“For years, Invibio’s PEEK-Optima polymers have been the preferred materials of choice for spinal interbody fusion devices” said Keith Cartwright, quality & regulatory leader of 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.”
The new ISO specifically covers Invibio’s tensile testing, flexural testing, determination of density by immersions testing, and differential scanning calorimetry analysis processes.
“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,” said Craig Valentine, regulatory affairs director of Medical & Regulatory Compliance. “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.”