Sequence Group delivered a comprehensive Quality Management System (QMS) overhaul for Empyrean Medical, focused on establishing robust generation change management processes across a growing radiation therapy product line.
The Challenge
As Empyrean Medical expanded its product portfolio from the SRT-100 to the SRT-100+, IORT System, and Sculptura, the existing QMS lacked structured processes for managing design and manufacturing changes across product generations. Inconsistent change controls and insufficient traceability created compliance risk.
Our Solution
Our team conducted a full gap analysis against ISO 13485:2016 and FDA QSR requirements. We designed and implemented a change management procedure, developed SOPs and work instructions, and built a training program deployed across engineering, manufacturing, and quality teams.
The Outcome
The updated QMS supported multiple successful FDA 510(k) submissions and regulatory inspections. Structured change management processes reduced engineering change approval times and eliminated recurring audit findings related to change control, enabling Empyrean Medical to scale its product line efficiently.
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Client
Empyrean Medical
Services Provided
- QMS Development & Implementation
- ISO 13485 Gap Analysis
- Change Control Procedures
- SOP Development
- FDA QSR Compliance
- Internal Audit Program
