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ISO 13485 Medical Devices certification

31 January 2009 ...

3T RPD Ltd is once again leading the way in the field of Rapid Prototyping and Manufacturing by being the first Direct Metal Laser Sintering (DMLS) bureau in the UK to be awarded ISO 13485:2003 Medical Devices certification. Being only the second bureau in Europe to obtain this certification, they are now able to supply certified components to the Medical Industry throughout the UK and Europe.

Recent acceptance of the DMLS process by the Medical industry will enable it to take advantage of the cost- and time- effective manufacture of patient specific instrumentation and implants. Surgical and medical devices can be manufactured directly from the CAD design; the reduction in leadtimes could open up new opportunities for custom devices being designed and manufactured for trauma patients. Furthermore, the process generates improved standard implants and instruments that are currently constrained by conventional manufacturing techniques.

In the short term, DMLS will enable the Medical industry to reduce development costs and increase opportunities for instrument development. Complex instruments for clinical trials can be manufactured and tested in theatre in just a few days, giving a reduced time to market and an improved product.

Firmly established as the UK’s largest Selective Laser Sintering (SLS) provider, 3T already recognise the need for continuous commitment to quality assurance in their manufacturing processes, products and delivery. As such, they obtained their ISO 9001:2000 certification in October 2007, and have the necessary systems in place to provide the highest levels of customer service and satisfaction, giving them preferred supplier status with many of their customers.

ISO 13485 is the international quality management standard for designers and manufacturers of medical devices, and is a pre-requisite for companies producing medical and biomedical products. In order to meet the regulatory demands of the Medical sector, it was imperative that 3T obtained the additional certification. It consolidates their commitment to supply their customers with compliant devices that are safe and effective.

Phil Kilburn, Medical Markets Manager of 3T RPD Ltd, says “The awarding of this certification demonstrates our long term commitment to the medical device market, whilst reinforcing the quality systems we already have in place. Our customers can be reassured that we are committed to operational excellence whilst ensuring the traceability of all the materials and components we supply for their medical applications.”

All material properties used in the DMLS process meet the chemical and mechanical specifications of standard cast parts, so CE marking can be obtained while large volume production methods and tooling are being developed. 3T already offer a choice of materials for the Medical and Dental industries; Cobalt Chrome alloy (EOS CC MP1) and Stainless Steel 15-5PH (EOS PH1); with pure Titanium (EOS TI) and Ti6Al4V alloy (EOS Ti64) available in the near future. Furthermore, Cobalt Chrome SP2 has been specifically developed for dental restorations, copings and bridges; the material is Beryllium- and Nickel-free and is fully biocompatible.

Ian Halliday, CEO of 3T RPD Ltd, summarises by saying: “As we continue to expand into new market sectors and develop our service offering, the ISO quality framework will ensure that we offer exceptional reliability and service, and the highest quality products that our customers have come to expect from us.”

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