Production and sales are organised under ISO 9001 and ISO 13485. Sterile ranges are manufactured in a GMP Class 100,000 dust-free workshop, packed and sterilised in house.
Certifications
- ISO 9001 quality management system
- ISO 13485 medical device quality management system
- CE marking
- FDA registration
- TGA (Australia) certification
Manufacturing control
- GMP Class 100,000 dust-free sterilised workshop
- Self-owned mould factory — tooling, sampling and changes stay in house
- Automatic production and packaging
- Medical grade ABS, polypropylene and nylon materials
- Lot-level release records and carton packing data (qty, CBM, N.W./G.W.) supplied with every shipment
Documentation for tenders
Certificates, test reports and packing documentation are available on request for hospital tenders and distributor registration.
