Reglera, LLC Achieves ISO Certifications for Medical Device Production and Quality Management System

April 27, 2009 - PRLog -- LAKEWOOD, CO - Reglera’s quality management system, including Reglera’s consulting services as well as its outsourced solutions, has been certified to ISO 13485:2003 and to ISO 9001:2000 by notified body BSI.

Technical committees comprised of members from many national standards organizations develop ISO standards. Consequently, companies awarded these ISO standard certifications are internationally recognized as upholding ISO’s quality standards as they apply to their own quality systems.

ISO 9001:2000, as defined by the International Organization for Standardization, specifies requirements for a quality management system where an organization needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements.

ISO 13485:2003, as defined by the International Organization for Standardization, specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

The 13485 standard certification is normally awarded to medical device manufacturers; however, due to Reglera’s outsourced products (such as a Document Control and Training program, and a Donor Eligibility Determination System), Reglera was one of the few consulting companies able to qualify for such a certification in December of 2007. Recently, Reglera’s consulting services have been ISO 13485 certified in addition to its outsourced products, meaning that every service Reglera performs for its clients is certified to both ISO 9001:2000 and ISO 13485:2003.

“We believe strongly in the quality standard ISO represents,” says Reglera President Clay Anselmo, “We are honored to be among the few consulting companies to receive this certification since it is typically awarded only to medical device manufacturers. It provides additional assurance to our clients that they are using products certified to the highest standard of quality.”

For additional information about Reglera, contact Tim Anschutz at anschutzt@reglera.com or call 800.341.4255.

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About Reglera, LLC: Founded in 1999, Reglera provides regulatory and quality assurance consulting and outsourcing services to both the medical device and human cellular tissue industries. Reglera’s unique combination of regulatory expertise and operations knowledge helps deliver results that combine regulatory compliance and process efficiency. With over 200 consultants and technical experts nationwide, Reglera is uniquely positioned to service clients from small start-ups to national and world-wide corporations.