The stakes in medical device manufacturing have never been higher. As products become more complex and regulatory expectations continue to evolve, the pressure to deliver faster, more efficiently, and with total traceability is growing every day.
In 2024, Cirtec made a strategic shift, moving from paper-based Device History Records (DHRs) to a fully digital, integrated electronic DHR (eDHR) system. What began as a pilot quickly proved a powerful truth: digital tools don’t just streamline compliance, they elevate operational performance.
In this Quality Magazine article, VP of Quality Assurance and Regulatory Affairs, Michael Schnabel, MBA, RAC-Devices shares how Cirtec successfully scaled digital quality transformation across a global organization.
Read the full article in Quality Magazine.