Once a new medical technology or device is ready to go from prototype to product, following a defined process and generating appropriate documentation is crucial. Regulatory bodies require specific documentation as evidence to determine the safety and efficacy of the product. These documents range from design input requirements to outputs like design specifications, manufacturing processes and risk analyses.


As we like to say, “If you don’t write it down, it didn’t happen.”


Internally, a design history file serves to document cross-functional team approval. This file also acts as a reference for future projects and iterations.


Our Approach To Design History File Generation

GCMI’s design and development team has significant experience following a rigorous product development process, generating a design history file along the way. We know the medical device development journey well, enough to choose good design strategies and foresee hidden land mines. Did you test your product performance early enough and often enough? Are you set up to pass your packaging test? What about final product performance?


We bring engineering skills, close attention to detail and a commitment to the development process. As a result, we increase the odds of a straighter, more cost-efficient pathway to regulatory submission, manufacturing and commercialization.


The medical device design services and product development team at GCMI facilitates medical product development through all phases – from initial concept generation through transfer to production manufacturing. We guide and execute along a strategic pathway, focusing on both product excellence and regulatory compliance. Our team works with a variety of innovators: individual physicians, researchers and engineers, start-up companies and publicly traded industry leaders.


Our Medical Device Design Services & Product Development Process

Project success is dependent on careful consideration of several intersecting aspects: technological, clinical, commercial and legal. We follow a structured, phase-gated process that allows for a disciplined medical device design and product development approach. Our medical device design services and development process encourages an early focus on clear problem definition and de-risking a wide variety of potential solutions. By later phases, the funnel of medical device design options narrows significantly, converging on a final product that has been thoroughly shown to meet the customer needs and is ready for distribution. Learn more about our process here.