EPTAM Precision Solutions Strengthens Enterprise Quality with Novunex eQMS
A single electronic Quality Management System brings greater consistency, compliance, and audit readiness across EPTAM's medical device manufacturing network
NORTHFIELD, NH, UNITED STATES, June 22, 2026 /EINPresswire.com/ -- EPTAM Precision Solutions ("EPTAM"), a Frazier Healthcare Partners portfolio company and leading precision contract manufacturer serving the medical device industry, today announced it has implemented Novunex eQMS as an enterprise quality platform across its manufacturing network.Now in use and being expanded across the network, the platform digitizes and standardizes EPTAM's core quality processes - document control, equipment and supplier management, issue investigation, nonconforming material, and corrective and preventive action (CAPA). For medical device OEM customers, the system supports greater consistency across EPTAM's multi-site footprint, faster access to quality records, improved visibility into quality-system performance, and a stronger foundation for new product introduction, validation, and production.
"Quality is not something you inspect into a product. It must be built into every stage of the process—from production and communication to verification, validation, qualification, and data retention," said Manny Nyakako, Vice President of Quality and Regulatory, EPTAM Precision Solutions. "Novunex eQMS connects our quality processes in a single system, improving standardization, traceability, and compliance readiness across EPTAM while helping our customers scale complex programs with greater confidence and deliver life-improving medical technologies to patients."
Built for regulated environments, Novunex eQMS supports ISO 13485:2016, FDA 21 CFR Part 820, EU requirements, and electronic records and signatures, with centralized documentation, configurable workflows, electronic approvals, role-based responsibilities, and traceable data to support inspection readiness.
"Medical device manufacturers need quality systems that reduce risk and keep teams aligned as operations scale," said Manfred Walder, Vice President of Operations, Novunex. "We're proud to support EPTAM with an eQMS platform built to strengthen compliance, visibility, and operational performance."
The implementation reflects EPTAM's continued investment in systems that reduce variability and support repeatable, scalable performance from development through validated production — giving OEM customers a quality foundation that grows with their programs and reflects the discipline behind EPTAM’s 'Reliability Requires Rhythm' operating philosophy.
About EPTAM Precision Solutions Founded in 1981 and headquartered in Northfield, New Hampshire, EPTAM Precision Solutions is a precision contract manufacturer of medical device components, single-use disposables, and finished device assemblies. Its capabilities span polymer and precision metal machining, injection molding, liquid silicone rubber molding, and laser cutting and welding, plus value-added services including rapid prototyping, process development and validation, cleanroom assembly, and technical program management. EPTAM maintains ISO 13485:2016, ISO 9001:2015, and AS9100D certifications, holds FDA Facility Registration, and operates ISO Class 7 and 8 cleanrooms. For more information, visit www.eptam.com.
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EPTAM:
Mary Jo Sysko,
VP of Commercial Development
msysko@eptam.com
616-304-3843
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Mary Jo Sysko
EPTAM Precision Solutions
+1 616-304-3843
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