Evolution Engineering

Evolution Engineering, LLC is a human factors consulting firm specializing in medical device research, design, and development. We have outstanding recognition in providing our clients with the guidance to obtain quality and compliance with all regulatory matters. Our services include: • Quality and Regulatory Affairs: We offer services in Strategic Quality Planning, Regulations, Quality Management Systems, Compliance, Auditing, Remediation, Gap Assessments, Regulatory Strategy, and Submissions. • Human Factors Engineering: We provide end-to-end Human Factors and Usability Engineering services. Examples of services include generative research, formative studies, and summative studies. • UI/UX Development: We specialize in developing complex user interfaces for medical devices, assessing existing user interfaces through heuristic analysis, and architecting and designing digital health products. • Instructional Design and Training Videos: We provide IFU/User Manual design, high-quality illustration drawing, rapid prototyping of instructions, and developing high-quality training videos for clinical and commercial use.