Reglera’s quality management system has been certified to ISO 13485:2003 and to ISO 9001:2000 by notified body BSI.

ISO 13485:2003 and 9001:2000 are international quality standards for medical devices and device suppliers. 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 superlative quality standards in their own quality systems.

This standard certification is normally awarded to medical device manufacturers; however, because Reglera’s outsourced products (such as a Document Control and Training program, and a Donor Eligibility Determination System) handle elements of the manufacturing process for our clients, Reglera is one of the first consulting companies able to qualify for such certifications.