Medical Device Testing Lab: A Flexible and Customizable Solution
Improvita’s medical device testing lab is a full-service facility for conducting Usability and Human Factors Testing. Human Factors/Usability Engineering is a required part of medical device and combination product development. A well-designed Human Factors/Usability Engineering Program includes Formative and Summative (Validation) Testing to generate objective evidence that a product is safe, effective, and easy to use.
Finding a suitable and customizable medical device testing lab can be a challenge for manufacturers who may not know where to start or how to conduct a thorough test to meet regulatory requirements. Improvita’s team of experts have the experience and skills to help your team develop a customized plan to conduct testing and will collaborate with you to write a report that illustrates how your device meets your user’s needs and regulatory requirements outlined in IEC 62366-1 and FDA’s Applying Human Factors and Usability Engineering to Medical Devices Guidance.
Discover how Improvita can address your Human Factors Testing requirements with our cutting-edge and customizable medical device testing facility.
Customization for Unique Needs
The Improvita medical device testing lab provides a customizable environment to meet the unique needs of your product and use environment. For example, our lab can be configured to simulate home, clinic, laboratory, and hospital use environments. Our team of experts will work with you to customize the environment with furniture, props, or other features per your testing requirements, which enable collection of key insights about user behaviors and perceptions which can be translated into improvements in design, instruction, and/or training that reduce the risk of product failure.
Facility Features
The Improvita medical device testing lab facility includes five testing rooms and two conference rooms. A training center is also available. In addition, the facility features a reception area where guests are warmly greeted upon entry, and a comfortable waiting area. The test rooms are different sizes, and each test room can be configured into an effective space to best match the test objectives and the real-world environment. Our experts will collaborate with you to determine which room or rooms will best represent your product’s use environment and workflow. The testing rooms are outfitted with state-of-the-art cameras and microphones, allowing for remote observation of testing procedures or sessions. Test sessions can be recorded for future viewing and source document record keeping. We also offer transcription, which can expedite the data processing and analysis. In addition, the environment of each room can be recorded with precision using calibrated equipment.
Conference Room Capabilities
The two conference rooms available at the Improvita Human Factors medical device testing lab provide a space for collaboration between medical device manufacturers, testing experts, and other stakeholders. The conference rooms can be used for on-site remote viewing of test sessions, training, focus groups, or meetings.
Why Choose Improvita’s Testing Lab for your Medical Device Testing?
Improvita’s Human Factors Testing facility can provide your team with full-service, high-quality Human Factors/Usability Engineering, medical device, software as a medical device (SaMD), software in a medical device (SiMD) and drug/device combination product testing with its customizable rooms and team of experts who will guide you through the process from start to finish.
Custom testing and environments are crucial to successful Human Factors Testing and give your team the best opportunity to effectively demonstrate the safety and effectiveness of your medical device, SaMD, SiMD or drug/device combination product.
Improvita will work with your team to reach your testing goals and highlight the benefits that your product can offer your users and patients while enabling collection of data needed by regulators to support product approvals.
To learn more about Improvita’s testing lab, contact us to discuss your specific needs.
