Contract Manufacturing

Austramedex has been manufacturing medical devices for over 30 years and is now able to offer its years of experience to others wishing to get into the medical device market. With colleagues in design, moulding and testing, Austramedex can help you get your product from concept to market.

Each of our customers are unique. We tailor our services to best fit their situation and specific needs. All work performed by Austramedex is in accordance with the relevant ISO guidelines.

Austramedex is ISO 13485: 2003 compliant

Our Services Include

Design Assistance

Part and tool design
Material selection
Prototype injection moulds for low cost design verification –A great way to test the market!
Sterile package and label design
Shelf and shipping box design and configuration

Material Procurement and Control

Vendor identification
Receiving inspection
Component and sub-assembly warehousing
Full lot control

Order Fulfilment

Warehousing of finished goods
Multiple times daily order processing

Process Development and Validation

Material selection
Prototype injection moulds for low cost design verification, great way to test the market!
Sterile package and label design
Shelf and shipping box design and configuration
Tooling and fixture design and fabrication
Validation protocol development, testing and reports
Sterile package seal strength characterisation
Sterilisation validation
Accelerated age studies

Product Manufacturing

In-process and final quality assurance 
Sterile packaging
Sterilization coordination
Final packaging

Device History Record/Master Record

Complete device manufacturing documentation (Technical File)
Complete work order history
Full lot control