Biomodex announced today that it received ISO 13485:2016 certification following successful third-party audits of its Boston and Paris facilities.
Boston-based Biomodex develops solutions for using an advanced-materials 3D printing process to deliver patient-specific models of blood vessels, aneurysms and other anatomies, simulating the same feel and tactile feedback as real patients, giving physicians the ability to train for procedures and learn how to use new devices.
The company said in a news release that it is currently working with hospitals and medical device companies across the U.S. and Europe to develop new applications and training programs for its technology.
ISO 13485 certification ensures that Biomodex offers consistent design, development, production, installation and delivery of medical devices that are safe for their intended purpose. The independent audit confirmed that the company met the certification requirements.
“I congratulate the entire team in Boston and Paris for this impressive achievement,” Biomodex president & CEO Ziad Rouag said in the release. “This is an important milestone for Biomodex. Achieving ISO certification not only strengthens our credibility as a company, it enables us to compete more effectively on a global level as we continue to expand into new markets. Obtaining this certification validates a commitment to quality to our growing list of clinical partners and customers worldwide. A special thanks to Intertek, our notified body, for flawlessly managing the certification process despite COVID restrictions.”