PI has full engineering capabilities across all disciplines required to develop sophisticated devices. A number of our projects have been IEC 62304 compliant for FDA regulated products.
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PI has full engineering capabilities across all disciplines required to develop sophisticated devices. A number of our projects have been IEC 62304 compliant for FDA regulated products.
Great product design is not an option; it’s critical for success. In each project we consider the bigger picture. We utilize a human-centred design approach to inform innovation allowing us to bring meaningful products and services to market.
The Planet Innovation engineering team consists of mechanical, mechatronics and CAD design, with a vast range of experience across the entire product development process with a focus on design for manufacture and robust production instrument.
PI has a rigorous quality system that is certified to ISO 9001 and ISO 13485 Medical Device Development. We have extensive experience developing biomedical devices for regulated US and European markets, including FDA QSR 820.30 Design Controls for Class II and III devices.
The software team at Planet Innovation has a broad range of experience developing software for medical devices, and other domains. We apply software development best practices such as Agile Development, Continuous Integration and Test Driven Design.
PI’s electronic engineering team is highly capable in the design of complex electronics for medical devices including: system architecture, schematic & PCB layout using Altium designer, loom design, prototyping, assembly and transfer to manufacture.
Planet Innovation has deep capability in the area of image acquisition and analysis for FDA regulated products. We have considerable experience in optical electronics along with mechanical and mechatronics optics capabilities.
Planet Innovation has its own internal manufacturing division for the manufacture of regulated products. We frequently provide a combination of development and manufacturing supply services to our clients in order to manage the delivery of high quality products to your end customer.
Our specialist systems engineering group is responsible for managing all the interfaces between the development groups. This begins at the early stages of developing project requirements and continues throughout the project monitoring key risks and performing in depth testing.
Planet Innovation has extensive formal project schedule and budget management processes in place and has an excellent track record in managing and delivering projects to schedule and budgets. We have an “open book” policy, often working very transparently with our clients to manage project expenditure.
Planet Innovation has onsite laboratories and a team of scientists including biochemists, molecular biologists and histopathologists with broad experience across all aspects of biomedical device development and associated assays and reagent test kits. Our scientists work as an integral part of the engineering and product development teams to develop highly effective diagnostic solutions.
Product-market fit means having a great product that is valued and meets the needs of a growing and sizable market. To help set you on the path to achieving product-market fit (PMF), PI has assembled a specialist team and developed a PMF program to thoroughly investigate the market and customer needs and recommend the best product solution, before you start designing.
Many companies develop great products that still go on to fail in the market because they lack a strong commercial strategy. To bridge this gap Planet Innovation built a specialized “Pitch^Big” team with capability to support start-ups and established companies ensure their commercial strategy is as strong as their technical strategy.