Press release - 28 November 2011
BSI Group America Inc., is pleased to announce that ClearCorrect, a provider of cutting-edge invisible braces for dental and orthodontic patients, has selected BSI to provide a total solution package that brings together certification, training and software to assist ClearCorrect’s compliance efforts. The solution will enable ClearCorrect to drive operational performance and manage complex regulatory requirements on the international level.
This robust solution is comprised of ISO 13485 certification, RABQSA-MD competency-based training, and Entropy Software, which will provide ClearCorrect with a focused management system approach streamlining business operations for improved management, transparency, and overall performance. “BSI understands the specific challenges faced by the medical device industry. BSI is one of the few service providers that can provide such a unique portfolio of solutions, and we are committed to providing this unsurpassed level of service.” said Todd VanderVen, BSI Group America’s President.
ClearCorrect will use Entropy Software®, a web-based tool, to provide a management system framework to easily conduct internal audits, manage non-conformities, and track preventive and corrective actions (CAPA) with seamless transparency, and real-time reporting. The Entropy Software solution supports ISO 13485 and FDA requirements, and will provide the foundation needed for entrance to the global marketplace.
“Implementing BSI’s portfolio of products and services for 13485 certification, RABQSA-MD training, and Entropy Software will allow us to quickly and efficiently manage our diverse regulatory and compliance needs for our international expansion,” said Colby Stracener, ClearCorrect’s Chief Operating Officer. “We are also excited to begin an all-encompassing relationship that will provide flexible solutions as we expand and grow in the future.”
BSI Healthcare’s mission is to ensure patient safety while supporting timely access to global medical device technology. We provide thorough, responsive, predictable conformity assessments, evaluations and certifications that are recognized and accepted worldwide.
Since 1901, BSI has provided customers with impartial third-party standards-based assurance, compliance, information solutions, and training. BSI is a trusted partner to Industry and Government with over 66,000 organizations, in almost 150 countries, working with over 50 BSI global offices.
ClearCorrect, LLC is a company created by dentists to serve the dental and orthodontic industry by providing a superior clear aligner system for patients. With cutting-edge technological advances combined with treatment expertise, the highly sophisticated ClearCorrect treatment delivery system and aligner products have years of research and clinical experience behind them. ClearCorrect, LLC takes a modern, needs-based approach for both doctors and patients. This unique orientation gives them the powerful position they hold in the industry.