Case Studies

By addressing its Quality Culture, our customer, a global medical device manufacturer, was able to address FDA and Notified Body concerns as well as improve
overall employee satisfaction and business results.

By addressing its Quality Culture, our customer, a global medical device manufacturer, was able to address FDA and Notified Body concerns as well as improve
overall employee satisfaction and business results.

A contract manufacturer of medical devices urgently needed to fill a critical gap left by the resignation of its VP of RA/QA. Complicating the situation: The manufacturer was addressing an FDA Form 483 that required weekly progress reports on the mitigation plan.

Under the guidance of Oriel STAT A MATRIX’s regulatory experts, our customer developed a company-wide CAPA program that addressed FDA concerns and resulted in a stronger, more effective global CAPA program.

Our customer, a manufacturer of Class II and Class III medical devices, received an FDA 483 finding that cited a weak Supplier Management system. The company was aware of this issue, but it did not have the internal resources to develop and implement the necessary corrective action.

Oriel STAT A MATRIX is supporting a large global Six Sigma deployment for more than 500 factories in 104 countries, including corporate centers, shared services, IT centers, and supply chain hubs. The client’s goals are to create long-term value and to serve
customer and consumer needs.

Oriel STAT A MATRIX helps to develop and implement an effective action plan that both rectified the violations and established sustainable changes that addressed the FDA’s concerns and enhanced the overall business quality functions.

Oriel STAT A MATRIX helps a specialty pharmaceutical and medical device company effectively implement a Six Sigma program that can rapidly identify cost savings without compromising customer service or jeopardizing FDA compliance.

Oriel STAT A MATRIX worked with the Panama Canal Commission to achieve ISO 9001 and ISO 14001 certification, developing and implementing customized quality and environmental management systems for the Canal Maritime Operations that they attribute with increased efficiency and profitability.

Oriel STAT A MATRIX partnered with Thailand's National Science and Technology Development Agency (NSTDA) in the development of a program to train Thai companies in achieving certification to ISO 9001. This certification provided Thai industry with an effective tool to improve its international competitiveness, resulting in increased corporate revenue, tax receipts, and foreign currency to the country.