42 Technology (42T) has today announced that the consultancy has been awarded ISO 13485:2003 certification for the design and development of medical devices, following an in-depth review of its management systems and processes.
42 Technology secures ISO 13485 for medical device designs
Securing this new standard will enable 42T to further strengthen its market offer and to work more closely with existing clients and prospects in helping bring innovative new medical products to market faster and at lower cost.
ISO 13485 is designed to demonstrate that medical device manufacturers, their design teams and sub-contractors follow a managed approach to all aspects of design, development and production with a strong focus on risk management and regulatory compliance. The standard builds on ISO 9001, which 42T has been working to for many years, and provides a base for compliance with the CE marking of medical devices for sale in Europe as well as requirements for other overseas markets, such as the US FDA design controls.
“Everyone at 42T has worked extremely hard in establishing and maintaining our quality management system so we are pleased to have it further endorsed by LRQA as meeting this exacting standard. Being awarded ISO 13485 is a significant development milestone and will be critical in helping build on our existing successes and track record in the medical devices and equipment market,” said Howard Biddle, managing director of 42T.
42T works with some of the world’s leading medical device, diagnostics and pharmaceutical companies to help design, develop and bring to market professional and consumer medical products. Recent successes include: developing a novel precision powder printing technology for GSK; developing a new patented aerosol technology with potential nebuliser applications; and working with FIND, the Geneva-based non-profit organisation on significantly improving the sensitivity of a new TB diagnostic.
42T’s certification of registration was issued on 25 January 2011.
The 42 Technology team of industry experienced physicists, engineers, industrial designers and analysts is expert at conceiving and developing novel products for efficient manufacture.