Improvita
Improvita is dedicated to improving lives through the development of innovative, patient-centered health solutions. With over 50 years of combined experience and more than 50 projects, the company guides clients in bringing safe and effective medical devices, software as a medical device (SaMD), and combination products to market. Improvita specializes in human factors testing, usability engineering, and regulatory compliance to ensure device safety, efficacy, and user-friendliness.
Industries
Nr. of Employees
small (1-50)
Products
Human Factors
Comprehensive study participant recruitment services for medical device human factors and usability testing, leveraging a proprietary participant database for targeted population sourcing.
Human Factors Validation
Professional consulting and execution services for medical device human factors validation studies, ensuring user interfaces can be used safely and effectively by intended users.
Human Factors and Usability Testing Services
Human Factors services designed to investigate patient comfort, ease of use, and privacy concerns when implementing monitoring procedures and using biosensors in clinical trials.
Medical Device Testing Lab
A full-service facility and customizable environment for conducting usability and human factors testing for medical devices, SaMD, SiMD, and drug-device combination products.
Medical Device Human Factors and Usability Engineering
Comprehensive consulting services to incorporate Human Factors and Usability Testing into the development of medical devices, software as a medical device (SaMD), and combination products to reduce use-related hazards.
Medical Device Labeling & IFU Human Factors Consulting
Human factors consulting and evaluation services focused on medical device labeling, packaging labels, and instructions for use (IFU) to ensure usability and reduce use errors.
Human Factors
Comprehensive study participant recruitment services for medical device human factors and usability testing, leveraging a proprietary participant database for targeted population sourcing.
Human Factors Validation
Professional consulting and execution services for medical device human factors validation studies, ensuring user interfaces can be used safely and effectively by intended users.
Human Factors and Usability Testing Services
Human Factors services designed to investigate patient comfort, ease of use, and privacy concerns when implementing monitoring procedures and using biosensors in clinical trials.
Medical Device Testing Lab
A full-service facility and customizable environment for conducting usability and human factors testing for medical devices, SaMD, SiMD, and drug-device combination products.
Medical Device Human Factors and Usability Engineering
Comprehensive consulting services to incorporate Human Factors and Usability Testing into the development of medical devices, software as a medical device (SaMD), and combination products to reduce use-related hazards.
Medical Device Labeling & IFU Human Factors Consulting
Human factors consulting and evaluation services focused on medical device labeling, packaging labels, and instructions for use (IFU) to ensure usability and reduce use errors.
Services
Customized human factors and usability engineering engagements for medical devices, SaMD, and combination products to reduce use-related risk and inform design.
Execution of formative usability studies and formal summative validation testing in controlled simulated-use environments with representative users.
Advisory services to align usability engineering processes and deliverables with IEC 62366 and relevant regulatory expectations.
Design, review, and user-evaluation of device labeling and IFUs, including application of human factors principles and label comprehension assessments.
Recruitment of representative users and healthcare professionals for multi-site and single-site usability studies.
Provision of controlled simulated-use environments and recording capabilities to support usability testing and human factors validation.
Customized human factors and usability engineering engagements for medical devices, SaMD, and combination products to reduce use-related risk and inform design.
Execution of formative usability studies and formal summative validation testing in controlled simulated-use environments with representative users.
Advisory services to align usability engineering processes and deliverables with IEC 62366 and relevant regulatory expectations.
Design, review, and user-evaluation of device labeling and IFUs, including application of human factors principles and label comprehension assessments.
Recruitment of representative users and healthcare professionals for multi-site and single-site usability studies.
Provision of controlled simulated-use environments and recording capabilities to support usability testing and human factors validation.
Expertise Areas
- Human factors engineering
- Usability testing (formative and summative)
- Human Factors validation for regulatory submissions
- IFU and medical device labeling development
Key Technologies
- Formative usability study methods (cognitive walkthroughs)
- Summative (validation) usability testing protocols
- System Usability Scale (SUS) integration
- Label comprehension studies
News & Updates
Improvita marks five years of providing innovative human factors testing and consulting services to improve medical device usability and safety.
Improvita celebrates the FDA approval of ZELSUVMI™, a treatment for Molluscum Contagiosum, developed with their human factors testing expertise.
Guidance on creating clear, effective Instructions For Use (IFU) for medical devices, including common pitfalls and considerations.
Improvita marks five years of providing innovative human factors testing and consulting services to improve medical device usability and safety.
Improvita celebrates the FDA approval of ZELSUVMI™, a treatment for Molluscum Contagiosum, developed with their human factors testing expertise.
Guidance on creating clear, effective Instructions For Use (IFU) for medical devices, including common pitfalls and considerations.