Meeting European MDR and FDA Compliance While Driving Product Improvement Across Multiple Regions
Konovo’s Medical Device Post-Market Surveillance Case Study illustrates how our always-on global insights platform enables medical device companies to meet stringent European MDR and FDA compliance requirements efficiently. Partnering with a cardiac device manufacturer, we conducted an independent 5-minute MicroSurvey with 66 cardiac nurses across Europe, the U.S., and APAC markets to gather unbiased, validated feedback. Within just eight days, our approach identified customer perceptions, validated satisfaction, revealed product improvement opportunities, and confirmed proper device function in real-world use. This cost-effective, research-oriented methodology provided balanced user insights, reduced internal resource demands, and empowered the client to enhance innovation and maintain compliance in the competitive medtech landscape.