BIOMODEX®, a pioneering digital health company that offers unique and enhanced 3D printed solutions for patient-specific rehearsal and physician training, today announced the company has received ISO 13485:2016 certification following successful 3rd party audits of its Boston and Paris facilities.
ISO 13485 is an international agreed upon standard that sets out the requirements for a quality management system specific to the medical device industry. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.
An independent audit conducted by Intertek confirmed Biomodex meets the requirements of the standard. This validation demonstrates the high standards and commitment to quality Biomodex employs during the design and utilization of its pioneering 3D-printed solutions for patient-specific rehearsal and physician training.
“I congratulate the entire team in Boston and Paris for this impressive achievement,” said Ziad Rouag, president and CEO of Biomodex. “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.”
Biomodex is set to revolutionize the way physicians approach complex procedures. The company offers innovative solutions that uses an advanced-materials 3D printing process to deliver patient-specific models of blood vessels, aneurysms, and other anatomies. These models simulate the same feel and tactile feedback as real patients, allowing physicians to train for procedures and learn how to use new devices. The company is currently working with hospitals and medical device companies across the U.S. and Europe to develop new applications and training programs that leverage the cutting-edge technology.
BIOMODEX® is a pioneering Digital Health company based in Paris and Boston. Starting from standard patient-specific medical imaging, Biomodex has developed a unique and enhanced 3D printed solution for patient-specific rehearsal and physicians’ advanced training, combining biomechanics and fluid dynamics (4D) and imaging properties (5D). The Biomodex solution offers a tailored precision medicine end-to-end physician experience.
The solution is fully integrated in both the imaging and procedural workflow, highly portable and easy to use. Image upload, ordering and quick delivery are facilitated through a web-based portal allowing customers to maintain their own portfolio. Dassault Systèmes supports Biomodex providing it with Cloud access to its design and simulation software and helping it transition to this environment. The solution is expected to result in reduced procedural and hospitalization costs, and improved acute and chronic outcomes. Biomodex has successfully commercialized several products for neurovascular and structural heart applications and is fast expanding its product portfolio through the application of its core technologies.