06.02.15
Swinton, England-based Magnesium Elektron, a contract manufacturing organization that makes high-performance magnesium alloys, has earned ISO 13485:2012 certification for its Synermag technology center in the United Kingdom. ISO 13485:2012 is an internationally recognized quality standard for medical devices.
Magnesium Elektron has been working closely with medical device companies worldwide 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 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,” said Graham Wardlow, managing director of Magnesium Elektron operations in the United Kingdom. “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 a manufacturing and testing facility that will fully support their development and production activities.”
ISO 13845:2012 certification means that Synermag’s alloy designs, manufacturing and business processes—including supplier controls, traceability and documentation—now are in line with medical industry standards.
“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.
Magnesium Elektron has been working closely with medical device companies worldwide 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 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,” said Graham Wardlow, managing director of Magnesium Elektron operations in the United Kingdom. “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 a manufacturing and testing facility that will fully support their development and production activities.”
ISO 13845:2012 certification means that Synermag’s alloy designs, manufacturing and business processes—including supplier controls, traceability and documentation—now are in line with medical industry standards.
“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.