Magnesium Elektron Achieves ISO 13485:2012 Certification for Its SynerMag Technology Centre
Magnesium Elektron, a world leader in the development, manufacture and supply of high-performance magnesium alloys, today announced the achievement of ISO 13485:2012 certification for its SynerMag(R) Technology Centre here. ISO 13485:2012 is an internationally recognized quality standard for medical devices.
Magnesium Elektron has been working closely with medical device companies around the globe for a number of years to develop and supply its SynerMag bioabsorbable magnesium alloys used in development of cardiovascular and trauma fixation implants. In 2012, the company established a dedicated manufacturing facility incorporating state-of-the-art laboratories, casting, extrusion and heat-treatment facilities.
Global research into bioabsorbable materials has increased significantly in recent years, particularly for vascular intervention and orthopedic trauma fixation in which the use of metallic implants is today commonplace. Magnesium is an essential nutrient for the human body and can be absorbed and broken down over time. Alloys based on the element offer the potential to combine the mechanical property benefits of metallic implants with the bioabsorbable nature of degradable polymers.
“This new ISO certification is a major milestone in our quest to take a leadership role in the development and manufacture of bioabsorbable metallic materials,” said Graham Wardlow, Managing Director of Magnesium Elektron operations in the U.K. “Every member of our SynerMag team played a critical role in implementing the highest levels of process control required to achieve this standard. We can now offer our medical device partners across the globe a class-leading manufacturing and testing facility that will fully support their development and production activities.”
ISO 13845:2012 certification means that SynerMag alloy designs, manufacturing and business processes-including supplier controls, traceability and documentation-are now in line with standards of the medical industry. “This level of quality control will provide confidence to our customers that their SynerMag supply chain will fully support their own medical standards, regulatory approvals and audits,” Wardlow said.
ISO (International Organization for Standardization) is the world’s largest developer and publisher of international standards. Magnesium Elektron’s ISO 13485:2012 certificate was awarded by Lloyds Register.
About Magnesium Elektron
Founded in 1936, Magnesium Elektron (www.magnesium-elektron.com) is an operating company of Luxfer Group (NYSE: LXFR, www.luxfer.com), a global materials technology company specializing in the design and manufacture of high-performance materials, components and gas-containment devices for environmental, healthcare, protection and specialty end-markets.
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