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Core's Mission
To infuse a human touch into every aspect of user research: serving our clients, connecting with study participants, collaborating with co-workers, and enhancing the safety and usability of medical devices and combination products.
Company Approach
Core’s human factors consulting approach emphasizes an intentional balance of usability, usefulness, and desirability. Our experts use human factors methodologies to uniquely address this equilibrium for clients in their precise tailoring of medical devices and combination products to the physical, cognitive, and perceptual characteristics of users. In acknowledging that medical errors continue to be one of the leading causes of death, we never compromise our values of prioritizing safety and providing high-quality work products.
We recognize that applying human factors and usability engineering to medical devices and combination products involves rigorous risk management for regulatory compliance and liability control. Our accomplished medical human factors team excels in navigating these challenges successfully.
Our experts support human factors activities and documentation for:
510(k), De Novo, and Pre-Market Approval (PMA) application submissions for medical devices
New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Biologics License Applications (BLAs) for combination products
Notified Body (NB) reviews, European Medicines Agency (EMA) submissions, and other regulatory bodies around the world
As a trusted business partner, Core offers an unparalleled breadth of experience and expertise. Each human factors consultant on our team collaborates closely with clients to accomplish the goal of completing the project in a timely and budget-conscious manner. Our commitment to service excellence, innovative ideas, and clear communication is notably appreciated by the clients we serve.
Whether clients require extensive support for a complex project or need advice for a simple review, Core is here to assist.
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