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.