Advent Access, an end-stage renal disease management medical technology company who designed and developed the av-Guardian™ Vascular Access System, is proud to share it has received ISO 13485:2016 certification for its Quality Management System from DEKRA Certification B.V.
ISO 13485 is an internationally recognized standard specific to the medical device industry for a quality management system. It is developed and published by the International Organization for Standardization (ISO), the world’s largest developer and publisher of voluntary international standards.
This is an important milestone for Advent Access as it demonstrates our commitment to the highest level of medical device quality controls, and meeting customer and international regulatory expectations.
Advent Access will continue to put patients first, and further our mission of reducing dialysis cost while improving the quality of life for end-stage renal disease patients.
We look forward to sharing more news of our upcoming developments in unlocking the future of dialysis.
Link to certification >