Certification validates company commitment to medical device quality and safety
Fluid Biomed Inc., developer of the world’s first bio-resorbable stent to cure brain aneurysms, announces it has received ISO 13485:2016 certification, the internationally recognized benchmark for Quality Management Systems (QMS) specific to medical devices.
“Fluid Biomed is committed to better health and quality of life through innovation, and we are developing unique life-saving technologies that are safe and effective,” said Dr. John Wong, Chief Executive Officer. “Although a young company, the team has individually and collectively dedicated themselves to nurturing and supporting a culture of quality focused on continuous improvement. We’re so proud to share that our Quality Management System has been independently audited by the leading national standards body, BSI, and is now certified to the rigorous and exacting requirements of ISO 13485:2016.”
ISO 13485 is the prevailing process-based QMS standard for the medical device industry around the world. Fluid Biomed holds certificate number FM 762811 and its QMS complies with the standards of ISO 13485:2016 for the design and development of intracranial stents and associated delivery components.