Ghent, Belgium – 3 November 2021 – Sequana Medical NV (Euronext Brussels: SEQUA, the “Company”), an innovator in the treatment of diuretic-resistant fluid overload in liver disease, malignant ascites and heart failure, today announces it has received Medical Device Single Audit Program (MDSAP) certification from its auditing organisation British Standards Institution (BSI), thereby expanding its Quality Management System (QMS) towards the U.S. and Canada.
The MDSAP allows competent auditors of recognised auditing organisations, such as BSI, to conduct a single audit of a medical device manufacturer’s QMS, which satisfies the requirements of the different regulatory jurisdictions participating to the programme (currently being Australia, Brazil, Canada, Japan and the U.S.). Sequana Medical’s QMS has now been certified according to the ISO 13485:2016 criteria and the applicable requirements of the U.S. Food and Drug Administration (FDA) and Health Canada within the scope of design, development, production and distribution of active implantable pump systems to transport fluids within the body.
Timur Resch, Global Vice President QM/QA/RA at Sequana Medical, commented: “This MDSAP certification is a major accomplishment and we are very proud of having this globally certified QMS in place. We at Sequana Medical are fully committed to regulatory compliance and continuously keep our processes and approvals up to date with changing and increasing standards worldwide. We are now working hard towards securing the Medical Device Regulation (MDR) certification, the new regulatory framework for medical devices in Europe, for our alfapump system.”
Ian Crosbie, Chief Executive Officer at Sequana Medical, added: “This certification is a significant achievement for our quality and regulatory team and demonstrates the commitment of the entire organisation in pursuing the highest quality standards required by the different regulatory authorities. It forms an important element of the package required for alfapump approval in the U.S. and Canada for patients with recurrent and refractory liver ascites. We look forward to completing enrolment in our North American pivotal POSEIDON study by the end of this year and reporting on the primary endpoint in Q4 2022 following the strong interim results reported earlier this year.”
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