Frontline Workers Are the Real Heroes
Human Factors MD would like to give a big shout out and thanks to all […]
Human Factors MD LLC is a "pure" human factors consultancy working exclusively with medical device and pharmaceutical clients.
We have a talented team of human factors experts with decades of experience researching, designing, and evaluating products for medical use.
Since our inception in 2001, we have helped some terrific companies create more usable, safe, and effective medical devices and combination products.
We utilize the science of human factors to help our clients' create safe, usable products.
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.
Human Factors MD would like to give a big shout out and thanks to all […]
Last month, Christina Mendat, PhD, Managing Director for Human Factors MD, was an invited speaker […]
by Liz Mauer, MHCI This is the fifth in a multipart series about how to […]
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