* All medical extrusions are produced in ISO 14644-1:1999 validated class 8 clean rooms in accordance with ISO 13485:2016.
* All finished medical device tube components processed in ISO 14644-1:1999 validated class 7 clean room in accordance with ISO 9001:2008.
* All finished tube tips are visually checked ‘in process’ using digital camera microscope and component development images can be issued for distance checking.
* Post production tube IDs/ODs checked with standard and custom pin and ring gauges.
* Class 4-6 clean room produced double bag packaging always used.
* Full technical data and regulatory compliance documents for raw materials used always available.
* Full original material and production batch traceability with every product shipment.
* Overall management system in accordance with ISO 9001:2008.
* Accreditation to ISO 13485:2016 is planned for Q3-4 of 2017.
