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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.
The Core Difference
Why do medical device and pharmaceutical companies love working with us?
Timely Support
Innovative Ideas
Quality Service
Clear Communication
Core Services
Listed below are some of the many human factors consulting services Core offers. We can provide a full suite of services customized to each client and project.
Research
Core conducts analytical and observational research involving all users, uses, and use environments. Whether clients need human factors formative testing, use-related risk analyses, a human factors validation study, or something else, Core is here to help.
Instructions for Use (IFU) Development
From the start of the design process, our experts utilize human factors analysis to develop designs that highlight safety and efficacy in the layout, images, and readability of the content.
Institutional Review Board (IRB) Services
With a focus on behavioral studies, a streamlined review process, and personal dedication to research ethics, we can offer quality IRB reviews to clients in a cost-effective, time-saving manner.
Participant Recruiting
Finding representative users can be a struggle, and scheduling participants for studies can be difficult. Utilizing our growing participant network and ongoing recruitment efforts, we can find representative users for research studies.
Human Factors Consulting Services, Inc. has joined the Rimkus Family of Companies as part of the Core Human Factors team. HFCSI provides human factors engineering and medical device consulting services, including user-centered design, usability testing, and risk assessments.
Philadelphia
1 Belmont Avenue, Suite 704
Bala Cynwyd, Pennsylvania 19004
United States
Los Angeles
9301 Oakdale Avenue, Suite 190
Chatsworth, California 91311
United States
Houston
12140 Wickchester Lane, Suite 200
Houston, Texas 77079
United States
We are here for you when you need us.
Call on us anytime. We are always happy to help.
Core Clients
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I have not had a chance to express in-person my appreciation for all the great work that you did with us and I wanted to let you know that I did find multiple opportunities to praise your work within [our company] as well as with acquaintances in the industry.
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On behalf of our entire team we would like to extend a "big thank you" to you and your team for your continued support with this important study. The achievements of this project is a true demonstration of the great teamwork we experienced on this team.
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I cannot say enough good things about the quality of work and the team’s ability to meet the requested timelines. [Core] did a great job and [we], including me personally, are very pleased with the results as well as the execution of both studies. I really enjoyed working with you and as well as everyone else on the Core team and I very much appreciate all their hard work.
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It was great to work with you and [the team], thanks for your excellent work!
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You did a fantastic job. Your style with the participants is amazing to watch.
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The questions being asked for the [product] part of the trial are effective!
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I am really pleased with how the study is going.
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We just wanted to send a quick message to thank you for all your help in the last year and wish you Happy Holidays! We are blessed to be able to work with such great people.
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Wanted to say thank you to you and your team. I learned a lot working with you.
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A huge THANK YOU for all of the hard work you did to help us prepare and execute the human factors validation testing. In short, FDA could not have been more effusive in their praise of our human factors methods, the quality and thoughtfulness that went into the protocol, and the clarity of the report. Thank you for being such great partners, and for helping us to make this incredibly important part of our submission so robust.
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[My project manager] specifically asked me to compliment you and the team for a very thorough and comprehensive piece of work!
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You are getting a lot of insight and information for our marketing team.
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This was very good work by all involved as we did meet the primary objective.
To learn more about Core's resources and insights, visit our blog for thought-provoking posts, articles, and news updates from our team members.
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