Usability Testing and MDR: Managing Risk with the Human Factor

Usability testing plays a key role in MDR compliance. Learn how early, structured testing helps reduce risk, improve device safety, and support regulatory approval.

Caroline Aernouts

July 23, 2025· Updated Mar 10, 20260 min read

Regulatory Affairs EU MDR

About the Author

Caroline Aernouts

View all articles

Navigate Regulatory Complexity with Confidence

Navigate complex regulatory landscapes with expert guidance across pharmaceuticals, medical devices, and IVD.

Share this article

Subscribe to the latest updates in life science

Expert perspectives delivered to your inbox — pick your interests.

No spam, ever. Unsubscribe anytime.

Keep reading

Regulatory AffairsMar 25, 2026

From R&D to Market: Why the Product Lifecycle Is the Strategic Framework for MedTech

Successful MedTech companies treat product development as a lifecycle strategy. Learn why regulatory planning, IP strategy and development must evolve together.

Regulatory AffairsMar 24, 2026

SaMD Under EU MDR: What Software Developers Need to Know

Developing Software as a Medical Device under EU MDR requires clear intended use, risk classification under Rule 11, and compliance with IEC 62304. Learn what SaMD developers need to know.

Regulatory AffairsMar 23, 2026

IP Strategy for MedTech Startups: What Early-Stage Companies Often Miss

IP strategy should start early in MedTech development. Discover how patent strategy, regulatory classification, and product development influence IP protection for emerging MedTech companies.