21st February 2013 – Oval Medical Technologies Ltd (‘Oval’), the privately held autoinjector development company, today announced that is has been awarded BS EN ISO 13485:2012 certification.
ISO 13485 is a quality standard certifying that the company has a comprehensive management system in place for the design, development and manufacture of drug delivery devices.
This standard provides an excellent framework of compliance which can be further developed to encapsulate the requirements of international market regulations such as 21 CFR 820 found in the United States.
“At Oval, we have worked very hard to support the implementation of our Quality system. Our assessor was very generous in their praise for our QMS system and particularly the co-operation of the team. We will continually develop the QMS as the company evolves by acknowledging the requirements of our customers and the industry. Very few businesses come this far in such a short period so we are very pleased with this achievement,” said Robert Emery, Oval’s Quality Manager.
Dr Catherine Beech, CEO of Oval, commented, “This is a fantastic development milestone for Oval Medical. The certification will help build upon the company’s success and reinforce Oval’s commitment to a high standard of design and development of medical devices. As Oval continues to grow it is essential that we have the appropriate systems in place to be a world class supplier to our current and potential customers.”