LIVONIA, Mich., March 16, 2018 – nanoMAG, LLC, a medical device contract manufacturing company, has received Certification to Registration of its Quality Management System to ISO 13485:2016. The scope of operations covers “The design and development and contract manufacture of magnesium-based alloy and composite materials for use in dental, orthopaedic, and surgical applications.” Notification of the registration, effective March 02, 2018 was received from the National Standards Authority of Ireland who conducted the on-site audits and reviews.
“The ISO 13485 registration is a significant milestone in the development and commercialization of our bioabsorbable magnesium alloy materials for use in medical devices,” says Stephen LeBeau, PhD, President of the Company.
Dr. LeBeau added “Our proprietary magnesium alloy, BioMg™ is a bioabsorbable, biocompatible material that provides appropriate temporary structural reinforcement, while avoiding all of the complications associated with current permanent metal alloy implants. Magnesium is a naturally occurring element in the body and is in fact prescribed in combination with calcium and phosphorus in numerous supplemental vitamin formulations to help maintain bone strength.”
About nanoMAG LLC
nanoMAG LLC, an engineered biomaterials manufacturer, is developing and commercializing next generation, high strength, lightweight magnesium (Mg) biocompatible materials with applications in orthopaedic medicine. This new class of materials provides the strength of steel but the ability to be safely absorbed by the body after the healing process is completed. The nanoMAG strategy is to partner with industry leading biomedical implant makers to design and develop metallic implants which are bioabsorbable. For more information, visit www.nanoMAG.us.
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President, nanoMAG LLC
13753 Otterson Court
Livonia, MI 48150