Improvita

Improvita is a human factors and usability engineering consultancy specializing in medical devices, combination drug-device products, and software as a medical device (SaMD). Based in Madison, Wisconsin, the company provides comprehensive testing and consulting services designed to support FDA regulatory approval and compliance with international standards like IEC 62366.

The firm's core capabilities center on formative and summative usability testing, risk management activities, participant recruitment of healthcare professionals and end users, and instructions for use (IFU) development. Their approach emphasizes early and continuous testing throughout the development lifecycle to identify use-related hazards and optimize user experience while ensuring device efficacy and patient safety.

Improvita has conducted multi-site participant recruitment across major U.S. cities and demonstrated expertise in complex validation projects, including FDA-mandated 522 postmarket surveillance studies for reusable endoscopes and decision support software validated using standardized Software Usability Scale (SUS) metrics.

Choose Improvita when regulatory approval success depends on rigorous, defensible human factors validation. Their specialized focus on IEC 62366 compliance and FDA submission requirements makes them particularly valuable for medical device companies facing complex regulatory pathways or responding to agency mandates.

Expect a structured, methodical approach grounded in risk management principles, with clear documentation and standardized metrics that support first-time FDA approval. Their experience with postmarket surveillance studies and ability to recruit diverse healthcare professional populations across multiple sites indicates capability to handle regulatory-critical validation work.

Improvita operates exclusively in the healthcare sector, focusing specifically on regulatory-compliant human factors testing for medical products. Their expertise spans medical devices used in clinical settings (such as endoscopes), pharmaceutical combination products, and software as a medical device. The company demonstrates deep understanding of healthcare-specific regulatory frameworks including FDA requirements and international standards like IEC 62366, with proven experience recruiting healthcare professional user populations for validation studies.

Medical device manufacturers preparing for FDA 510(k) or PMA submissions who need compliant human factors validation. Companies developing combination products or SaMD requiring IEC 62366 conformance. Organizations facing FDA mandates for postmarket surveillance or usability revalidation of existing devices.