Vision Automation for Medical Device Manufacturing
Marking, labelling and vision automation for medical device production, engineered in-house, validated to ISO, FDA and MDR, and supported across their working life.
Production challenges in medical device manufacturing
Medical device manufacturers carry a regulatory burden no other sector matches. Every system on the line has to be specified, validated and documented to a standard that holds up in an audit.
The demands the systems we build have to meet
Regulatory compliance: ISO, FDA and MDR requirements mandate validated production processes, documented quality control and full traceability across the production lifecycle.
UDI: Unique Device Identification (UDI) obligations require accurate labelling, verification and data logging for every device produced.
Zero-defect quality: Patient safety demands near-zero defect rates, requiring automated inspection, real-time defect detection and reject systems.
Validation and documentation: Production systems must support IQ/OQ/PQ validation protocols with audit-ready documentation and compliance reporting.
Sterile packaging integrity: Automated inspection of sterile barrier packaging, seal integrity and contamination control.
Bespoke automation solutions for medical device production
We deliver bespoke solutions in marking, labelling and vision automation. Each area can be specified as a standalone system or engineered together as a turnkey automation solution for your production line.
Turnkey Bespoke Automation
Deliver complete custom-engineered, end-to-end automation systems for complex medical device production requirements. From initial specification and design through to build, commissioning, validation (IQ/OQ/PQ) and ongoing support.
Vision and Inspection
Automated inline systems for the inspection of medical devices, components and assemblies in real time, detecting dimensional errors, surface defects, incorrect assembly, foreign material (matter) and missing components.
Labelling and Packaging Automation
Automated labelling systems for UDI labels, product identification, tamper-evident labelling and compliance labelling on medical device packaging.
Coding, Marking and Compliance
Laser marking, inkjet coding and direct part marking for permanent product identification and traceability.
Robotics and Material Handling
Precision robotic assembly systems for medical device component handling, placement and assembly. Robotic pick-and-place for packaging lines, automated material transfer in cleanroom environments, and end-of-line palletising.
Software, AI and Digital
AI-based vision inspection for advanced defect classification. Production data logging, traceability reporting and compliance documentation. Connection of inspection, labelling and serialisation data to MES and ERP systems for regulatory reporting.
Validation and compliance support
We provide Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) documentation alongside the equipment, and our engineering team supports you with audit-ready data logging and traceability reporting and ongoing maintenance and support.
ISO, FDA and MDR are the standards to which we work.
UDI and serialisation are the data obligations we support.
Typical applications
- UDI labelling and verification on orthopaedic implants, surgical instruments and diagnostic devices.
- Automated inspection of syringes, catheters, implantable devices and diagnostic equipment.
- Sterile packaging inspection for single-use devices, surgical kits and barrier systems.
- Component assembly verification for multi-part devices and sub-assemblies.
- Barcode and serialisation verification for product and batch traceability.
- Label and leaflet inspection on device packaging, cartons and secondary packaging.
- End-of-line quality assurance with automated rejection of non-conforming devices
Why medical device manufacturers work with AIS Vision Automation
Validation support (IQ, OQ, PQ) and audit-ready compliance documentation.
30+
Years Experience
70+
Engineers
1000+
Projects Delivered
ISO
9001:2015 certified
Proven Solutions in Production
We've delivered vision automation solutions for manufacturers across Ireland and Europe. Here's how we've solved specific production challenges.
