Case Study: Sorenson Medical strengthens compliance and streamlines quality management with MasterControl

Sorenson Medical, Infusion Pumps Innovator, Turns to MasterControl to Strengthen Compliance

Sorenson Medical, maker of the ambIT ambulatory infusion pumps that deliver precise pain control for patients, is committed to strict FDA and international quality standards but was hampered by a “home-grown,” partially electronic quality system. Manual routing, paper packets for approvals and weekly engineering change meetings created bottlenecks, risked lost files, and made it difficult to ensure compliance with 21 CFR Part 820 and ISO/CE requirements.

In 2004 Sorenson implemented MasterControl Documents, trained users, and centralized its documentation and approval workflows on a web-based platform with electronic audit trails and automatic revision control. The system gave remote access to released documents, eliminated the weekly ECO meeting, cut document review and approval from about a week to a day, and streamlined audits — helping Sorenson maintain certifications and ensure audit-ready compliance.