Ionbond announced today the successful ISO 13485:2003 certification of its UK service centre. It is the first Ionbond centre globally to be awarded the certification and also the first Physical Vapour Deposition (PVD) surface engineers in the UK to achieve ISO 13485:2003 certification.
Artificial knee joint coated with a ‘Medthin’ coating from Ionbond that prevents corrosion, minimizes wear and greatly reduces metallic ion concentrations.
“ISO 13485:2003 defines the role and responsibilities of service organisations for safe and effective medical devices,” explains Dr Chris Constable, UK General Manager at Ionbond. “Our rapid certification reflects the high priority Ionbond places on coatings for medical devices.” An internationally recognised standard, ISO 13485:2003 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.
Common platform “This certification demonstrates our commitment to the highest internationally recognised standards of process control and product verification,” says Dr Constable. “It provides a common basis for development and qualification of solutions together with our clients – both now and for the future.” Ionbond UK is also certified to ISO 9001:2008, AS 9100 (Aerospace) and NADCAP (Aerospace) and maintains a comprehensive quality management system, providing an excellent foundation for ISO 13485:2003. Ionbond has a broad portfolio of advanced bio-compatible PVD coatings including titanium nitride, zirconium nitride and A-DLC. These coatings are approved for use in medical devices – with further innovative developments in the pipeline.
Certification around the world Joe Haggerty, CEO at Ionbond adds: “This is the first of several certifications that are in progress to fully develop our worldwide network of coating centres devoted to medical coatings. Our goal is to have a network of seven sites with ISO 13485 certification within the next 12 months including Switzerland, the USA, China, Malaysia and two sites in France."
For more information please contact: [email protected] or see www.ionbond.com
