IRRAS Receives Quality System Certification under MDSAP and Updated European Union Medical Device Regulation 2017 / 745
· IRRAS’ Quality Management System has been confirmed to comply with stringent standards required under both MDSAP and EU MDR programs, which also extends the company’s existing ISO 13485:2016 certification · After completion of MDSAP audit, IRRAS can now pursue product regulatory clearance in its next wave of key markets, including Australia and Brazil · Successfully completing the MDR quality audit is needed first step to qualify IRRAS’ products for CE Mark under new MDR requirementsStockholm, June 8, 2021 – IRRAS AB, a commercial-stage medical technology company with a