Design and Development .
Our facilities.
Our facilities include a 30,000 square-feet dedicated healthcare design, development, and manufacturing plant located at our global headquarters Castlepollard, Ireland. Our cleanroom environments meet ISO Class 8 standards to ensure the production of sterile medical components.
Our approach to quality and regulatory affairs.
Mergon Healthcare upholds strict compliance with relevant regulatory standard ISO 13485, to ensure the manufactured blow moulded, injection moulded and medical device components meet required quality and safety standards.
Our quality laboratory facilities support critical to quality dimensional testing for batch release. We use certified external partners for drop testing, ageing, DSC and CT scanning. We have a proven track record of successfully navigating regulatory approvals for medical devices including MDR technical file preparation.
Our Partners.
Mergon has an extensive international network of expert partners whom we work closely with to optimise outcomes for our customers.
Healthcare Product Lifecycle.
Mergon Healthcare has high maturity design, development, and manufacturing capabilities through the full product lifecycle. Mergon has a tenured team of Healthcare manufacturing professionals with deep technical competency in Healthcare programme management , product design and industrialisation
Product Design Development
- Program Management
- Mechanical Design & and predictive analysis
- Full Product Design Controls
- Regulatory submission & CE marking support
- Requirements Development & Management
- Risk Management
- Reliability Modelling and Statistical Analysis
- Design for Manufacture for large scale production
- SolidWorks
- CETOL 6σ 3D Tolerance Analysis Software
Mould Tool Design and Build
- Mould tool vendor selection
- Tool build specification (>CpK 1.66 requirements)
- Tolerances and inspection controls spec
- Prototype solutions to produce robust quality parts
- Pilot production for stability and clinical batches
- High cavitation injection moulds for large scale production
- Mould flow analysis
Blow and Injection Mould Manufacturing
- Injection Moulding (20 to 650 ton across group)
- Validated Injection Moulding of components
- Validated automated Ultrasonic Welding and assembly
- Validated Automated bagging
- Validated automated product testing using closed loop pass/fail
- Pressure Decay Leak testing
- High Voltage Leak testing
- Weight Checker
- High Volume Continuous Extrusion Blow Moulding— up to Quadruple Head
Product Automated Assembly
- Mergon Innovation centre built automation
- 30+ Multi-axis robots
- 15+ Vision systems
- 15+ Automated assembly cells
- Closed loop testing of complex components and systems.
- Cobot systems, with advanced cameras and AI to augment human quality checks
Finished Packaging and Quality Release
- Batch release per IS013485 principles
- Certified for manufacture and release of sterile devices
- Experienced in blister pack and Tyvek sealing
- Experienced in pretty pack and bulk pack operations
Don’t see what you’re looking for?
We are always innovating and trialling new solutions for the healthcare sector.
Contact us today about solutions to suit your business.
