We will continually develop the QMS as the company evolves by acknowledging the requirements of our customers and the industry. Our assessor was very generous in their praise for our QMS system and particularly the co-operation of the team. “At Oval, we have worked very hard to support the implementation of our Quality system. ![]() 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. 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. 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.
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