Ensure process efficiency with a comprehensive Quality Management System

In medical device manufacturing, the constant possibility of product recalls requires early identification of potential problems. Design errors are a significant cause of quality issues. Early involvement from engineers in a quality-by-design approach and closed-loop management maintains patient safety and cost control and ensures faster time to market. Our Closed Loop Quality and Compliance tools ensure process efficiency, offering a comprehensive Quality Management System (QMS) with integrated capabilities.

Maximize quality with our integrated process efficiency tools

Our integrated process efficiency tools offer a comprehensive solution, allowing you to leverage Risk & Requirements management, conduct Failure Modes and Effects Analysis (FMEA) and plan for quality. They ensure the maintenance of a complete Design History File (DHF) and Device Master Record (DMR), facilitating a seamless design transfer to production. Additionally, these tools support continuous improvement through integrated complaint management, Corrective Action Preventive Action (CAPA) processes and change management.

Read our ebook to learn more about quality process efficiency.