Core provides a full suite of services customized to each client and project.
How do real people use your product? Do they know what it is meant to do? Do they pick it up the correct way? Do they push the right buttons? Do they understand what they are doing with it while remaining safe? We can find these answers for you in all kinds of ways.
You can learn how people use your products from our lab behind a one-way mirror, from their homes, or from their workplaces.
Examples include Competitive Evaluation Testing, Contextual Inquiry, Formative Usability Testing, International User Research Interviews/Surveys, Labeling Comprehension Studies, Summative Usability Testing, Self-Selection Studies, Validation Testing.
Are the instructions for your product written clearly? Can a range of people understand them? Does your product look professional?
Our illustrators and researchers can design your Instructions for Use (IFU) to improve users' experiences.
From optimal font size for readability to layout to recommendations for print stock, our designs rely on human factors analysis and focus on safety and efficacy from the beginning of the design process.
Are the rights and welfare of the study participants adequately protected? Are the risks sufficiently minimized and reasonable? Will the participants be adequately informed about the study?
Are you struggling to find representative users? Have you found it difficult to schedule participants for studies?
What will Authorities Having Jurisdiction (commonly referred to as regulatory agencies) expect from your human factors and usability engineering program? How can you design your human factors validation study so that you pass the first time? Are you in conformance with the international standards (including 62366-1 and HE75)?
We help large and small companies around the world navigate local and international regulatory processes to bring products to market.
With our decades of experience spanning hundreds of products, we will advise you on the best regulatory strategies.
Our experts have worked on all of the major international standards regarding human factors of medical devices (including apps), pharmaceuticals, and combination products. We can advise you on the safety requirements set forth by regulatory agencies.