Global Center for Medical Innovation

Book of Knowledge

The GCMI Book of Knowledge contains:

Phase 0

Feasibility

In this pre-QMS phase, all the messy details are worked out and de-risked. This is critical to ensure that not only can a device safely and legally be brought to market, but that the market and business strategy will support its adoption.

Phase 1

Concept

In the first Design Controls phase, plans for regulatory compliance, testing, manufacturing, and risk management are established. A Design History File begins here.

Phase 2

Design & Development

In this phase, the design is frozen to allow the commencement of test article production required in later stages. All known risks must be addressed to avoid wasted time and capital in the later stages, which become increasingly costly.

Phase 3

Verification

In this stage, testing is performed on clinically-equivalent devices produced in an ISO13485 Quality Management System. Tests such as transit simulation, mechanical testing, and accelerated aging may be performed.

Phase 4

Validation

In this stage, the real test of the clinical value of the device is examined by assessing its effectiveness in the actual intended contexts of use.

Phase 5

Manufacturing Transfer

In this stage, the device has been de-risked and there is high assurance of its regulatory approval. Supply chain, logistics, and sales operations will be spooled up to coincide with regulatory and IP milestones to ensure a successful and profitable launch.

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