Medical Device Industry

Location: USA, East Coast

Overview: 

Companies in the medical device industry face many challenges in today’s highly regulated marketplace. Manufacturing high-quality products and delivering them on time while complying with strict government regulations, particularly those issued by the Food and Drug Administration (FDA), has become increasingly challenging for many companies. SQA has a proven record of success in consistently providing professional expertise and solutions that are designed to address the needs of this industry.

One of the most respected manufacturers of medical devices has recently called in SQA to provide management consultancy and to analyze and improve their measurement systems. It is critical for all manufacturers to identify, analyze and minimize the variation in their measurement systems.

Objectives:

To analyze and improve the measurement systems, SQA is performing Gauge R&R studies on all of the gauges of this manufacturer of medical devices. This statistical tool, which is used also in other industries, analyzes the amount of variation in a measurement system arising from the measurement device and from the operators that are taking the measurements on the product.

For this, SQA created and deployed a system with a team of quality professionals that are conducting these studies and implementing solutions to improve the measurement systems

Results:

With the help of SQA, the manufacturer:

• Knows that all of the gauges currently in operation have been carefully analyzed by SQA and are found to be suitable for their specific applications.
• Has an easy-to-use, adaptable system for measurement system analysis where users are able to view the status of the Gauge R&R studies via rich dashboards with easy to understand process metrics and configurable reporting.
• Maintains world-class operations while meeting FDA regulations.