PredictImmune makes further strides towards January launch of PredictSURE IBD, by gaining ISO 13485 medical devices certification
Certification demonstrates PredictImmune’s on-going commitment to the provision of high-quality processes to support the development of its in-vitro diagnostic pipeline.
Cambridge, UK, 18th December 2018: PredictImmune, developers of pioneering prognostic tools for guiding treatment options and improving patient outcomes in immune-mediated diseases, today announced confirmation of its ISO 13485 certification.
Achieving this BSI standard is another signficant step forward in PredictImmune’s progress towards the January 2019 launch of its first prognostic biomarker test, PredictSURE IBD™. Compliance with ISO 13485 is often seen as an integral step in achieving compliance with European regulatory requirements. The conformity of medical devices and in–vitro diagnostic medical devices, according to European Union Directives 93/42/EEC, 90/385/EEC and 98/79/EEC, must be assessed before sale is permitted, and one of the major requirements to prove conformity is the implementation of a Quality Management System. PredictImmune’s certification demonstrates its ability to provide in–vitro diagnostic devices and related services that consistently meet both customer and applicable regulatory requirements. It is also confirmation that the organisation has the high-quality processes in place to support the end-to-end life cycle of in–vitro diagnostic devices. Having recently also been awarded CE IVD (European Conformity In–vitro Diagnostic Medical Devices) certification for PredictSURE IBD™, the stage is now set for PredictImmune to take the test to market across the UK and Europe as of January 2019.
“Gaining ISO 13485 status less than 18 months after the company was formed is testament to the commitment and hard work of the PredictImmune team”
Paul Kinnon, CEO commented of the accreditation: “2018 has been an extremely busy year for PredictImmune. Over the last few weeks particularly we have consolidated and validated our business proposition with a number of successes, including new patent grants across the UK, EU and Canada, the announcement of a joint study with the US Crohn’s and Colitis Foundation, CE IVD certification for PredictSURE IBD™ and the award of an Innovate UK grant.
“We are proud to add the ISO 13485 accreditation to these achievements. This further demonstrates both our commitment to continual improvement and the consistent implementation of appropriate processes and procedures, including the operation of a robust quality management system. Gaining ISO 13485 status less than 18 months after the company was formed is testament to the commitment and hard work of the PredictImmune team, the company founders, and the support of our investors.”
For information: www.predictimmune.com
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