top of page
what we KNOW

As human factors experts, and former aviation and emergency medical professionals, our motivation has always been to optimize human-product performance in complex use environments through the application of human factors science, to enable safe, effective, and enjoyable user experiences. 

FDA human factors and usability expert
FDA human factors, design controls, MDR, ISO14971, IEC62366
our EXPERTISE

OUR AREAS OF EXPERTISE INCLUDE:

  • observational field research, ethnography, and contextual inquiry

  • task, workflow, and use error analyses

  • user experience and (graphic) user interface design

  • information architecture

  • (rapid) prototyping, wireframes, and mock-ups

  • usability testing, (FDA) formative and summative

  • human factors & usability eng. in agile development, i.e. SCRUM

  • human factors & usability eng. for medical devices and combination products 

  • design controls and ( risk management, i.e. ISO 14971

  • FDA, MDD/MDR, IEC 62366, and international usability standards for medical devices

​

With our dual-market – US and EU, multi-disciplinary background, and our bilingual capabilities – English and German, we can provide insight into tackling the complexities of applying human factors within the medical device research and development process whilst providing a clear regulatory path for FDA submission and CE mark approval.

types of devices we've SUPPORTED

computer-aided aortic occlusion catheters | electrophysiology 3D mapping systems | fluid-management systems | cardiac programmers and monitors | integrated OR imaging and surgical navigation solutions | pre-filled syringes | pressure and volume control ventilators | drug reconstitution self-administration kits | surgical fluid irrigation pumps | infusion pumps | insufflators | surgical generators | surgical robots and tools | diagnostic catheters | implantable devices | acoustic coupling fluid | radiological equipment | AF ablation catheters | autoinjectors | endoscopes | cardio ultrasound | surgical software for minimal invasive surgery

we know MEDICAL DEVICES
& COMBINATION PRODUCTS

For two decades we have supported development teams around the globe by researching, designing, engineering, and testing their devices, empowering them to develop the safest and most effective human-focused products possible. We prioritize enriching usability, user experience, user safety, and patient quality of life through the application of human factors science and usability standards. 

we know REQUIREMENTS
REGULATIONS & STANDARDS

We are competent in both US and EU human factors and usability regulatory requirements and can aid in ensuring alignment between FDA guidances, IEC 62366 standards, MDD/MDR regulations, and international human factors and usability standards.

HFUX  FOUNDER
medical FDA human factors and usability engineering expert

Heidi M. M.

Founder and Principal Consultant

  • LinkedIn

Human Factors and Usability Expert for

Medical Device Research and Development

​

Our founder, Heidi Mehrzad, is an experienced human factors consultant with deep expertise in the application of human factors science and usability practices in the product research and development industry. She founded HFUX Research in 2017 with the vision to empower organizations around the globe, at every budget, knowledge level, and development stage, to realize their human factors vision and usability goals by employing customized human factors and usability strategies and solutions tailor fit to each organization's needs.

 

With her diverse professional experience as a trained pilot, emergency medical technician, software analyst, and human factors and usability expert within the medical device and combination product development industry, her motivation has been directed towards enhancing human-product performance by optimizing user interface design, information architecture, and user and product workflow, through the application of human factors science and usability guidelines and practices. 

​

She holds patents in GUI design for medical imaging and surgical navigation software systems. She grew up in Germany and has had previous human factors and research roles in the U.S., Luxembourg, and Switzerland. She is bilingual in German and English and holds a BS in Aeronautics and an MS in Human Factors and Systems, both from Embry-Riddle Aeronautical University. She also holds technical degrees in Information Technology Management and Emergency Medical Services from Sacred Heart University and Daytona State College.

bottom of page