St. Ann, MO., June 5, 2012
“This is an outstanding achievement for everyone at DynaFlex and a testament to our focus on quality” said Darren Buddemeyer, CEO of DynaFlex. “Gaining ISO certification can be a major challenge for any organization, but for us to have achieved both ISO 13485:2003 and MDD 93/42/EEC simultaneously is superb and an accomplishment we are very proud of as a company. These achievements further illustrate that the management systems we have built within DynaFlex, and the processes through which we care for our clients are to the very highest international standards.” Buddemeyer concluded.
ISO 13485:2003 is the internationally recognized standard for quality management within a business in the medical device industry. It provides a systematic and common sense approach to ensure that the activities within the business are controlled, aiming to consistently achieve customer satisfaction by meeting their requirements and expectations.
MDD 93/42/EEC (The MD Directive) is a ‘New Approach’ Directive and consequently, in order for a manufacturer to legally place a medical device on the European market, the requirements of the MD Directive have to be met. Manufacturers’ products meeting ‘harmonized standards’ and have a presumption of conformity to the Directive. Products conforming to the MD Directive must have a CE mark applied. The Directive was most recently reviewed and amended by the 2007/47/EC and a number of changes were made. Compliance with the revised directive became mandatory on March 21, 2010.
About DynaFlex DynaFlex is a leading provider of Orthodontic Products, Orthodontic Custom Lab Manufacturing, Sleep Apnea Appliances, and Digital Orthodontic Products and Services. Established in 1965, DynaFlex is now one of the fastest growing Orthodontic Supply & Lab providers in the industry, providing outstanding customer service, combined with the best products, high quality manufacturing, state of the art technology, and a market leading unique proactive leadership approach.
For additional information, please contact:
ISO and Quality Manager