WE ARE A LEADING PROVIDER of human factors design and evaluation services.
Since our inception in 2001, we’ve worked exclusively with pharmaceutical and medical device clients providing HUMAN FACTORS EXPERTISE at every step of the development and regulatory approval process.
Exploratory Research, In-Situ Observation, Focus Groups and Interviews, Comparative Use, Marketing Claims, Validation Testing, Sharps Handling
Use-Related Risk Analysis, Threshold Analysis, Usability Bench Tests, Ergonomic Assessments, Annex C Reviews, Process Gap Analysis
Instructions for Use, Carton and On-Device Labeling, Warning and Precaution Labels, GUI Interaction and Visual Design, Instructional Videos and Training Materials
Eye Tracking, Tachistoscopic Metering, Retrospective Performance Probing, Time and Motion Analysis, Workflow Mapping, Post-Market Data Mining
We have only ever worked on medical devices. We understand the challenges unique to medical devices. And human factors is all we do. 24/7/365.
We’ve helped many clients through the regulatory approval process, including aiding with successful 510(k), PMA, NDA, BLA, and ANDA applications.
We do the heavy lifting for you. We author study protocols, obtain IRB approvals, recruit end-users, host or source facilities, QC and analyze data, and draft reports; all in accordance with our Quality Management System.
Our facility in Charlotte was designed for usability testing of medical devices and includes exceptional video and audio recording and streaming, multiple simulated-use contexts, and meeting and private areas for client use.
Our technical directors have an average of more than 18 years experience as human factors experts supporting medical device development.
We’re well versed in the regulatory requirements for human factors in the US and ROW. We are up-to-date on all FDA Guidances, the MDD/MDR, and international standards for medical device design.
We have a talented team of human factors experts with decades of experience working with patients and HCPs, researching, designing, and evaluating medical devices and combination products.
Our TECHNICAL DIRECTORS have an average of 18 years of commercial experience as human factors professionals supporting medical device design teams.
by Liz Mauer, MHCI This is the fifth in a multipart series about how to […]
by Liz Mauer, MHCI This is the fourth in a multipart series about how to […]
by Liz Mauer, MHCI This is the third in a multipart series about how to […]
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