Medical Human Factors Solutions
Human factors engineering solutions for medical device teams who want support in understanding and meeting regulatory expectations and making usable products that meet their users needs.
Services
I provide human factors expert training, feedback, and guidance to medical device teams, whether you're about to do a summative, you're ready to submit to a regulator/notified body, or if you just want to improve your team's human factors practices to stay on the leading edge.
Training
On-site or remote team training on human factors process, regulatory expectations, and best practices.
Review
Review and give actionable feedback on your summative protocol or regulatory submission so you can go forward with confidence.
Jason Sterkenburg, PhD
I am the Principal at Human Factors Advice. I obtained my PhD in Human Factors & Cognitive Science from Michigan Technological University and I've spent nearly a decade in medical device development, building human factors programs and supporting successful regulatory submissions (e.g., 510k, IDE, EU MDR).
I'm passionate about sharing my knowledge and equipping others to drive human-centered design practices in their daily work.
Contact
Reach out if you have questions or want to discuss collaboration.