Exsurco Achieves ISO 13485 Registration for Medical Device Design & Manufacture

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An ISO 13485:2003 Certificate of Registration was awarded to Exsurco Medical. This manufacturer of unique, technologically advanced devices and tools for tissue processing was able to meet the requirements for this international standard for quality management systems for medical device manufacturing showing the company's continued commitment to customers in the tissue processing fields.

ISO 13485 registration illustrates the significant investment that Exsurco Medical has made in the quality systems needed to design and manufacture its products for the market.

Exsurco Medical, Inc., a leading-edge innovator and manufacturer of unique, technologically advanced devices and tools for tissue processing, announces that it has been successfully registered according to ISO 13485:2003, the international standard for quality management systems for medical device manufacturing.

Exsurco Medical was awarded a Certificate of Registration by BSI Group America, Inc., a leading certification body offering management systems certification services to industrial and medical companies.

ISO 13485:2003 is a globally recognized standard for establishing and using quality management systems that consistently meet customer and regulatory requirements for safe and effective medical device manufacturing.

Exsurco followed a rigorous process to successfully achieve its registration. ISO 13485:2003 registered organizations must have systems in place to comply with important regulatory items including risk management and quality management, plus documentation, document control and control of quality records.

Sara Ann MacKinlay, general manager, stated that achieving ISO 13485 registration was a natural next step for Exsurco. “We’ve made significant commitments to customers in the tissue processing field,” MacKinlay said. “ISO 13485 registration illustrates the significant investment we’ve made in the quality systems needed to design and manufacture our products for the market.”

“We’re pleased that we were successful in ISO registration on our very first attempt,” MacKinlay added.

According to MacKinlay, ISO 13485:2003 registration is an important new milestone for Exsurco in that it underscores the company’s intent to expand its activities to serve the broader needs of the tissue bank industry and beyond.

As a manufacturer of technologically advanced devices and tools for tissue processing, Exsurco Medical’s mission is to improve technician and clinician efficiencies through simplifying and speeding up tissue-related procedures such as skin and bone debridement. Several new products introduced by the company within the past two years have proven their success in the market, with sales approaching $2 million.

Designed and manufactured in the USA, Exsurco’s products are supplied to customers in North America, Europe and other countries. Website address: http://www.exsurco.com.

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Sara Ann MacKinlay, General Manager
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