Product Development

Our Advanced Product Development stage progresses the design, development, and verification of your product, including packaging and labelling.

PI has full engineering capabilities across all disciplines required to develop sophisticated devices including mechanical engineering and CAD, industrial design, mechatronics, electronics, software, optics,  manufacturing and science.

We also possess full equipped internal workshops, biochemistry science laboratories, test and reliability laboratories and sophisticated 3D printing capabilities.

FDA QSR compliant product development processes are applied, as required, with a strong emphasis on design for manufacture. We also provide significant experience in:

  • CE, TGA & FDA regulatory environments
  • Clinical 510K & PMA submissions
  • ISO13485 compliant manufacturing processes
  • Post-launch QA/RA processes eg. CAPA, complaints/MDR

As your product is progressing on the development journey, manufacturing processes and commercialization plans are developed in parallel to minimize the time-to-market and maximise the reliability of your final product.

Stage 2

Advanced Development

Objectives
  • 1Design, develop and verify the product or process.
  • 2Develop supporting processes eg.manufacturing.
  • 3Complete commercialization plans.
Activities
  • 1Develop prototypes.
  • 2Develop detailed design.
  • 3Verification testing.
  • 4Establish quality systems.
  • 5Establish IP protection.
  • 6Marketing trials of early product or process.
Deliverables
  • 1Alpha and Beta prototypes.
  • 2Bill of materials if appropriate.
  • 3Design test plans.
  • 4Design transfer plan.
  • 5Launch plan.
  • 6Commercialization plan.

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