Human Ability Designs brings extensive experience, commitment to safety, scalable solutions, and regulatory ready deliverables to help you improve the success of your human factors regulatory submissions, processes, in house team expertise, and medical device user interfaces. Led by a biomedical engineer expertly trained in human factors engineering, we join each client team to help your organization develop and bring to market medical products that are safe, effective, usable, and accessible for end users of all abilities.
We provide regulatory-ready solutions led by an experienced biomedical engineer with extensive leadership and engineering expertise who has reviewed the human factors work of hundreds of teams to help produce optimized user interfaces (product, labeling, training) as well as first time successful regulatory human factors engineering submissions.
Human Ability Designs is led by a qualified professional, industry thought leader and seasoned expert who is passionately invested in helping you optimize the use-related safety, efficacy, usability and accessibility of your medical devices and combination products. Our scalable approach ensures your design meets user needs and your submission achieves human factors regulatory approval.
The number of users with conditions that cause temporary or permanent physical, sensory, and cognitive limitations is continually increasing, and these limitations often influence the safe and effective use of medical devices. Human Ability Designs has extensive experience planning, executing and analyzing studies with diverse users with disabilities, including building strategies and rationales for surrogates.