Our Commitment to Developing World Class Manufacturing and Quality Systems
The management team at Lighthouse Imaging is committed to continually improving our manufacturing and quality systems. Our quality management system has received both ISO 9001 and 13845 certification and our facility is a FDA Registered Facility, compliant to CFR 820 Medical Device regulations.
- Advanced ERP Systems
- Allows for the control of all materials from procurement throughout manufacturing while providing material traceability for the life of the device.
- Bar coding system enables tracking of serialized devices
- New investment in an EPDM system
- Electronic document control system
- Provides version control and historical traceability of all revisions for both Drawings and Documents
- Utilize a full Project Management Software suite
- Rigorous Incoming Inspection
- Inspection plans are developed in accordance with risk factors developed during Design phase and in accordance with industry standards.
- Materials are received, inspected and released according to inspection procedures and drawings
- In accordance with cGMP, we have full lot control and traceability on all materials, processes, operators.
- Done through lot number assignment, serial number assignment, work order tracking and color-coded labeling
- Decades of development of Precision European & Domestic optics vendors for advanced components
- Network of Asian sources of optical components used in production for over a decade
- Broad range of PCB and electronics suppliers, distributors both domestically and internationally.
- Mechanical and machined componets with quick turnaround from domestic vendors in Maine, Massachusetts and NY are used for majority of production
- Cost reduction opportunity available using overseas vendors for components and subassemblies
- All suppliers are monitored for performance under our Quality Management System.