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East Lyme, CT, June 9, 2009, — Birk Manufacturing, a recognized leader in the design and manufacture of flexible heating elements, announces today that it has received ISO 13485 certification for its Medical Device Quality Management. Companies that achieve ISO 13485 certification must meet the stringent product quality requirements of the International Organization of Standardization (ISO). ISO 13485 certification involves demonstrating best practices throughout all stages of a product’s lifecycle: from prototype through manufacture.
“We are delighted and proud to receive this highly coveted certification,” remarked Norman Birk, President and founder of Birk Manufacturing. “When we opened our doors twenty years ago, we knew we wanted to set ourselves apart in the industry. The route we chose was an unwavering commitment to quality in everything we did. Earning this certification honors that dedication.”
SO 13485 is like a stamp of approval recognized throughout the world . “The benefits to our customers – both international and domestic – go beyond quality assurance,” commented Mr. Birk. “ISO 13485 certification provides our customers real savings in terms of cost and time to market. All of the pre-qualification has already been done by ISO. This gives us the ability to hit the ground running full-speed, and deliver fast turnaround on prototypes and production.”
In fact, it’s this reliable demonstration of quality that makes ISO 13485 certified companies, like Birk Manufacturing, so desirable to the medical device community, where the most exacting standards exist. According to ISO, “To be accepted for development, a proposed work item must receive the majority support of the participating members of the ISO technical committee which, amongst other criteria, verifies the ‘global relevance’ of the proposed item – this means that it indeed responds to an international need and will eventually be suitable for implementation on as broad a basis as possible worldwide.”* For the medical device industry, knowing a manufacturer’s operations have been so thoroughly evaluated and tested means the device will perform as promised.
Founded in 1989, Birk Manufacturing is a leading provider of flexible heating elements and thermal systems. Responsible for numerous innovations throughout its twenty-year history, Birk Manufacturing applies its expertise to all phases of product development – from design to manufacturing.