Medical Device Contract Manufacturing
Austramedex has been manufacturing medical devices for over 20 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.
General List of Services
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:
- Part and tool design
- 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
Design Assistance
- Tooling and fixture design and fabrication
- Equipment validations including I/Q, O/Q and P/Q
- Validation protocol development, testing and reports
- Sterile package seal strength characterization
- Sterilization validation
- Accelerated age studies
Process Development and Validation
- Vendor identification
- Receiving inspection
- Component and sub-assembly warehousing
- Full lot control
Material Procurement and Control
- Full lot control and/or serialization
- In-process and final quality assurance
- Sterile packaging
- Sterilization coordination
- Final packaging
Product Manufacturing
- Warehousing of finished goods
- Multiple times daily order processing
Order Fulfilment
- Complete device manufacturing documentation (Technical File)
- Complete work order history
- Full lot control
Device History Record/Master Record
For further information on how Austramedex can help you bring your product to market please contact us.