High-Precision Mould Making
Precision moulds engineered for micron-level repeatability, cleanroom-ready integration, and ISO 13485-certified production. Built under strict controls to ensure traceability, reliability, and full compliance in medical manufacturing.
Tooling Designed for Regulatory Performance
We engineer every mould to meet the traceability, compliance, and performance demands of ISO 13485 environments. From single-cavity validations to high-output serial runs, our tools are built for process accuracy, cleanroom readiness, and full regulatory alignment.
- Pilot & Pre-Series Tooling
Single and low-cavity tools built for first-shot accuracy, IQ/OQ/PQ compatibility, and clinical-grade material testing. All tooling is manufactured in climate-controlled conditions with full ISIR, CPK analysis, and documentation to support cleanroom transfer and design freeze.
- Serial Tooling
Our serial tools are engineered for high repeatability and consistent performance in cleanroom environments. With hardened stainless steel construction, efficient thermal management, and optimised ejection systems, they reduce maintenance needs and downtime. High-precision cavity balancing, process capability analysis, and interchangable components support reliable inspection reports and long-term production stability.
End-to-End Mould Expertise for Regulated Markets
We support medtech, pharma, and biotech innovators with precision-engineered tooling workflows, from concept validation to serial production. Our integrated engineering, tooling, and qualification systems are built to meet ISO 13485 requirements, cleanroom compatibility, and validation traceability.
- Engineering Support - 39 years in mould making, DFM/DFMA approach, Design freeze validation
- Mould Design - CAD/CAM for tight tolerances, Modular, interchangeable layouts, Downtime-minimised builds
- Mould Manufacturing - Micro-milling and 5-axis EDM, Cavity balancing and fast cycles, Hardened steel for longevity
- Mould Qualification - IQ/OQ/PQ ready, ISIR, CPK, SPC reporting, In-house Try-Out Center
Advanced Moulding Techniques for Functional Integration
We engineer moulds with a focus that goes beyond geometry, optimised for functionality, reduced assembly, and full regulatory compliance. From overmoulding metal inserts to integrating labelling in the mould, our tooling ensures final-part performance straight from the injection moulding machine.
- Scientific Moulding Approach - Our tooling and moulding setups follow a scientific approach, using in-mould sensors to monitor cavity temperature and pressure, optimise gate freeze timing, and control each phase of the injection process. This ensures precision, consistency, regulatory compliance, and supports full traceability.
- In-Mould Assembly & Labelling - We engineer moulds that integrate subcomponents and labels directly during injection moulding. This eliminates secondary steps, enhances part cleanliness, and supports traceability in high-volume manufacturing environments.
- Metal Overmoulding & Reel-to-Reel - To ensure precise placement and secure adhesion of metal components, we engineer inserts and runner layouts with accuracy in mind. Thermal and mechanical bonding is achieved with minimal shift tolerance, ensuring consistent encapsulation performance across production.
