Our Commitment
Setting New Standards in Medical Device Manufacturing
Lucas Lifecare is committed to advancing healthcare through cutting-edge medical devices and integrated services. Our team is dedicated to setting new standards in reliability, performance, and patient safety, empowering healthcare providers with innovative solutions that improve patient outcomes.
Lucas Lifecare
Lucas Lifecare develops and distributes high-tech medical products designed to enhance, nurture, and preserve the quality of life. We are a company that believes in world-class practices, integrity, and top-notch service.
At Lucas Lifecare, we give you “World Class Quality with Midwest Service”.
Our Manufacturing Process
Design & Engineering
We start with user needs and risk analysis, transforming them into designs that are carefully reviewed, tested, and validated before moving into production.
FDA-Aligned Quality Systems
Our Quality Management System complies with 21 CFR Part 820 (QSR) and is transitioning to the new FDA Quality Management System Regulation (QMSR), aligned with ISO 13485.
Supplier & Material Controls
Only approved, qualified suppliers provide raw materials and components. Incoming inspections ensure compliance with our strict standards.
Controlled Manufacturing
Each step of production is validated and documented, from assembly to sterilization, ensuring consistency across every device.
Calibration & Testing
We use validated test methods and calibrated equipment so that every measurement and performance check is accurate.
Traceability & Records
Our Device Master Records (DMR) and Device History Records (DHR) provide full traceability, proving each unit is built to spec.
Labeling & Packaging
Devices are packaged to protect against damage, labeled with UDI (Unique Device Identifier), and shipped ready for global compliance.
Post-Market Vigilance
We monitor device performance in the field, respond to customer feedback, and implement corrective and preventive actions (CAPA) to continuously improve.
