Project Solution: Medical Device

The Challenge A Midwestern diagnostic company desired to bring a DNA based diagnostic to market as an FDA approved medical device. The device would be cleared through the FDA PMA approach and would be the companies first FDA approved medical device. A parallel submission (FDA/CMS) would be utilized.  The technology represented an innovative, groundbreaking approach […]

The Challenge A large mid-western pharmaceutical company desired to develop and implement a GMP service provider quality assessment/management program.  The company had developed a corporate level procedure but had not develop local procedures or practices to allow effective implementation and use.  additionally, the concept of supplier quality assessment was new to the company. The Solution […]

 The Challenge A leading medical device manufacturer sought to add a new product to an existing production line. This required a retrofit of the previously validated line, requiring an assessment to determine if existing documentation met current regulatory standards. Additionally, new processes and simple fixtures were being added to the production line to accommodate the […]

The Challenge A Fortune 500 medical device manufacturer wanted to add a new laser welder to their production facility to improve manufacturing throughput and reduce scrap rate. The engineering staff at the medical device company were familiar with the equipment and its intended use; however, this model of laser welder had not been previously used […]