MASS Group Unveils TME® 8.0: A Modernized Interface for Enhanced User Experience and Operational Performance
TME® helps you achieve total traceability, compliance, and operational control in a regulated, fast-moving environment—all in one platform.
Medical device manufacturers face intense regulatory oversight, complex documentation requirements, and the need for full traceability from raw material to packaged product.
With TME®, you get a configurable MES that streamlines compliance, manages work order execution, enforces cleanroom controls, and integrates seamlessly across your tech stack—without costly customization.
Real-Time Production & Cleanroom Monitoring
Monitor machine performance, environmental conditions, and process parameters in real time to ensure compliance and reduce risk.
TME® MES keeps your operations running at peak efficiency, using conditional logic to proactively respond to deviations, support cleanroom standards, and meet the high production demands of regulated medical device environments.
Controlled Work Order Execution
Intelligently routes work orders based on cleanroom classification, operator training, and equipment readiness—ensuring that regulated processes are performed under controlled, validated conditions.
GMP Equipment & Calibration Management
Monitors calibration schedules, usage thresholds, and preventive maintenance for GMP-critical tools and equipment—ensuring traceable, validated processes that meet FDA and ISO 13485 requirements.
TME® helps maintain accuracy, repeatability, and audit readiness while minimizing the risk of equipment-related nonconformances.
Serialized Inventory & UDI Traceability
Manages serialized and lot-tracked inventory across the full device lifecycle—ensuring end-to-end traceability from raw materials through final assembly, labeling, and distribution, including full UDI compliance and audit-ready documentation.
With TME® Inventory Management, medical device manufacturers can optimize resource allocation, minimize lead times, and ensure that every aspect of the inventory process aligns with the high standards required.
Performance Analysis & Reporting
Our Performance Analysis & Reporting features deliver real-time insights into critical manufacturing KPIs, helping medical device manufacturers identify trends, optimize cleanroom operations, and support data-driven compliance.
TME® captures everything from equipment utilization and yield rates to defect tracking and nonconformance analysis—ensuring full visibility across validated processes and audit-ready reporting.
In-Process Quality Control & Compliance Automation
TME® provides full traceability and automated audit trails across the entire medical device manufacturing lifecycle—from raw material intake to final packaging and distribution.
Our platform supports in-process quality control with auto-hold logic, nonconformance tracking, and inspection checkpoints, ensuring every step is validated and documented to meet FDA, ISO 13485, and DHR requirements. With streamlined access to compliant records and comprehensive audit histories, TME® simplifies regulatory reporting and reinforces quality and accountability at every stage.
Integrated Compliance & Execution Systems
Ensure the highest standards of compliance by tightly controlling process parameters, product specifications, and validated procedures across every stage of medical device manufacturing.
TME® integrates seamlessly with ERP, QMS, and test systems to synchronize BOMs, routings, and quality records—enabling full alignment between planning, production, and compliance. This connected approach supports FDA and ISO 13485 requirements while delivering the traceability and control regulators and customers expect.
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