Our microfluidic manufacturing capabilities are designed to support your product's success from pilot production through to high volume manufacture.
We are certified to ISO 13485:2016 for the design, development and manufacture of micro-engineered medical and diagnostic devices. What's more we understand how ISO and regulatory requirements can make or break a product's commercial success.
Our Quality Management System is certified ISO 9001:2015 and is designed to ensure that everything we manufacture is exactly fit for purpose, meets the intended specifications for quality and safety, and complies with regulatory requirements.
All of our manufacturing activities occur under a strict GMP framework. The ultimate goal of our adherence to GMP is the safeguarding of consumer and patient health through the maintenance of uncompromising product quality and consistency.
Our extensive cleanroom facilities are designed and built to ISO 7 cleanroom standard. The 800 sqm meter cleanroom area features ultra-filtered air, cascading pressure differentials, air-locks and procedural controls to ensure these spaces remain free of contaminants.
Everything we do is driven towards one end goal - high precision replication for mass manufacture. Our tooling, injection moulding and supporting infrastructure currently delivers millions of high precision products to market every year.
The range of bonding technologies at our disposal is designed to support automated high volume manufacture as well as lower volume pilot production. These technologies include thermal, laser, solvents, adhesives, US welding and more.
Manufacturing tolerance is only meaningful when backed by the ability to measure it. Our advanced metrology systems include a wide range of precision measurement systems to verify nano-scale physical dimensions as well as enclosed channel depth, surface roughness, fluorescence, light transmission, mass, surface profiles and film thickness.
We specialize in polymer based hybrid products that integrate specialized injection molding resins and extruded films with metal deposition, chemical coatings, electroformed films, ceramics, electrodes, biosensors, reagents and PCB
Our expertise doesn't stop at the production line. We also have an established third party logistics partner able to provide ISO 13485 certified supply into North America, Europe and Asia.