product
development.

Faster development. Smarter design. Fully compliant.
Work with our specialist team to take your concept from idea to manufacture-ready.

All design, development, and engineering is managed in-house under our
ISO 13485-certified quality system.

Providing a comprehensive design & development service including;

  • Design for manufacture (DFM), usability, and risk-based design
  • In-house 3D scanning for rapid development and reverse engineering
  • Full Systems engineering aligned with regulatory and QMS requirements
  • Seamless transition to in-house manufacturing with full traceability
  • Finite element analysis (FEA) and design verification for performance evaluation
  • Full regulatory compliant documentation

Our experience

  • Class I through to Class III medical devices, including high-risk implantable devices, surgical instruments, procedure kits, and consumables
  • Patient-matched implants, guides, and anatomical biomodels
  • Sterile procedure kits for orthopaedics (trauma and sports medicine), gastro-urological, and colorectal procedures
  • Devices developed for a range of global markets, including FDA, TGA, EU, and more
  • Collaboration with start-ups through to global medical device partners