Uncompromising on Quality

At Smithstown Light Engineering, quality is at the heart of everything we do. Accredited to major industry standards, including ISO 13485 and ISO 14001, we implement stringent quality control measures to ensure the production of ultra-precision medical device components used in life-saving surgeries worldwide.

Our Quality Management System guarantees full control over every stage of the manufacturing process, from raw material selection to final inspection. We maintain complete traceability of all materials and purchased parts, ensuring compliance with the highest industry standards and regulatory requirements.

Process Focused Team

Our dedicated management-led Quality Team implements world-class quality standards in manufacturing and product verification to assure the integrity and reliability of every component we supply. They work hand-in-hand with our customers and our engineering and manufacturing teams while embracing our culture of quality, compliance and continuous improvement.

Smithstown also prioritises continuous staff training and development, ensuring that our highly skilled workforce remains at the forefront of advanced manufacturing and quality assurance methodologies.

Quality Management

ISO13485, ISO14001 certified

FDA Certified

Full material traceability, FDA registered site, PPAP processes

Quality Control

Environmental and temperature controlled QC laboratory

3D Scanning

7 x Carl Zeiss CMMs with 3D scanning heads, ideal for reverse engineering and digitizing

Smartscope

9 x OGP Smartscope vision inspection systems

Skilled Staff

Continuous Training & Development for our process focused team

Precision Assured

Our quality department is equipped with 7 Carl Zeiss Coordinate Measuring Machines (CMMs), utilising the latest 3D scanning software for unparalleled accuracy in measurement and inspection. These machines operate in a controlled environment, maintaining a stable temperature of 20°C ± 1° and humidity levels below 55% to ensure precise and repeatable results.

See our other inspection equipment here

Zeiss O Inspect Smithstown Light Engineering

3D Scanning and Digitizing

Our Zeiss CMM’s are equipped with a VAST scanning head allowing us to offer our customers a comprehensive reverse engineering service by scanning and digitizing your component and providing a 3D CAD model to our design team for product modifications or for supplying technical drawings.

Zeiss Vast Head at Smithstown Light Engineering

Process Validation

As your trusted MedTech manufacturing partner, we offer full process validation and compliance with Production Part Approval Process (PPAP), including:

Process maps
Risk analysis
First article inspections
Process capabilities assessments
Failure Mode and Effects Analysis (FMEA)
Gauge R&R studies

Every project we undertake includes detailed inspection reports covering actual measurements of critical dimensions, ensuring compliance with ultra-tight tolerances. We also provide certificates of conformance for complete transparency and regulatory assurance.

Uncompromising on Quality

Process Focused Team

Precision Assured

3D Scanning and Digitizing

Process Validation

Our Locations

Shannon Site 1

Shannon Site 2

Poland Site