Contract Manufacturing

19/12/2014

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.

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

  1. Part and tool design
  2. Material selection
  3. Prototype injection moulds for low cost design verification, great way to test the market!
  4. Sterile package and label design
  5. 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 characterization
  • Sterilization 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