Our skilled engineers employ a broad range of technical experience during the early development stages of a project from initial concept to finished product. This allows us to offer sound advice during the early project stages with regard to component design for manufacture and material selection to achieve optimal product specifications.
Our experienced engineers use mould simulation analysis software coupled with conducting risk analysis methods (such as PFMEA) and are able to identify potential quality or reliability risks early thus, in conjunction with the customer, can adjust the design to eliminate issues before production commences.
With an optimised design intent, we complete a structured optimisation of the injection mould process to lead into process validation that captures all relevant elements of Installation, Operational and Performance Qualification.
Process validation is essential to the manufacture of medical devices and an integral part of our business. The validation activities we undertake are in line with FDA and ISO 13485 requirements and ensure we continually strive to produce safe and effective devices.