Online from: 1954
Subject Area: Mechanical & Materials Engineering
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Article citation: , (2012) "Ionbond emphasizes medical device solutions with ISO 13485 certification", Anti-Corrosion Methods and Materials, Vol. 59 Iss: 2, pp. -
Ionbond announced the successful ISO 13485 certification of its Swiss service center in Olten. It is the forth Ionbond centre globally to be awarded the certification.
“ISO 13485 defines the role and responsibilities of service organizations for safe and effective medical devices,” explains Dr Antonio Santana, Product Manager Medical Europe at Ionbond. “Our rapid certification reflects the high-priority Ionbond places on coatings for medical devices”.
An internationally recognized standard, ISO 13485 assures a harmonized set of quality management system requirements for medical device manufacturers and service providers. This standard is currently being adopted by the medical industry and regulatory agencies around the world.
“This certification demonstrates our commitment to the highest internationally recognized standards of process control and product verification,” says Dr Santana. “It provides a common basis for development and qualification of solutions together with our clients – both now and for the future”.
Ionbond Olten is also certified to ISO 9001 and 14001 maintains a comprehensive quality management system, providing an excellent foundation for ISO 13485. Ionbond has a broad portfolio of advanced bio-compatible PVD coatings including titanium nitride, zirconium nitride and ADLC. Marketed for a number of years under the trade name Medthin™ these coatings are used by a large number of customers for implants and instruments. These coatings are approved for use in medical devices – with further innovative developments in the pipeline.
Joe Haggerty, CEO at Ionbond adds: “This is the forth of several certifications that are in progress to fully develop our worldwide network of coating centers devoted to medical coatings. Our goal is to have a network of seven sites with ISO 13485 certification by mid 2012 including the USA, China, Korea, England and two sites in France.”
More information is available from: www.ionbond.com