Usability Testing
Summative Evaluation / Human Factors Validation for Medical Devices
Summative Evaluation is the final Human Factors Usability Validation Test that confirms whether users can safely and effectively operate a medical device without unintended use errors. This validation is a critical requirement for regulatory submissions and verifies that your device meets real-world clinical demands.
Summative Evaluation Explained
What Is Summative Evaluation?
Summative Evaluation is a formal Human Factors Validation process conducted at the final stage of medical device development. Its purpose is to verify that intended users, such as clinicians, nurses, technicians, or patients, can operate the device correctly, safely, and consistently under realistic conditions. This validation must be performed without additional guidance, prompts, or training, ensuring that the user interface (UI), instructions for use (IFU), labeling, and workflow design fully support safe and effective use.
As a critical component of IEC 62366-1 compliance and a key requirement under MDR and FDA Human Factors Engineering guidance, Summative Evaluation provides the objective evidence regulators expect to see before granting market approval. It confirms that all critical tasks can be performed without hazardous use errors, usability-induced risks, or workflow failures that could compromise patient safety. The Human Factors Validation study demonstrates not only functional safety, but also that the overall user experience, task design, and interaction flow align with real-world clinical environments.
Summative Evaluation is essential for final risk assessment, usability documentation, and regulatory submission. By proving that your device supports safe and effective use in a realistic clinical context, this validation step ensures readiness for CE marking, MDR conformity assessment, and FDA 510(k), De Novo, or PMA submissions. It also strengthens confidence among stakeholders by showing that the device has been rigorously tested from a Human Factors and Usability Engineering perspective.
Our Approach
Summative Evaluation Overview
A well-structured validation approach ensures that Summative Evaluation provides reliable regulatory evidence. It verifies that your medical device supports safe behavior, clear usability, and consistent performance across diverse user groups and clinical settings.
Engaging an external Human Factors team brings objectivity and eliminates development bias, a crucial requirement for both FDA and European notified bodies.
1.
Review Use Specification
Confirm intended users, use environments, and all critical tasks requiring validation.
2.
Finalize the Design
Ensure UI, labeling, instructions, and interactions represent the final product version.
3.
Prepare Validation Protocols
Develop IEC 62366-1 and FDA-compliant scenarios, task lists, metrics, and acceptance criteria.
4.
Conduct Summative Usability Testing
Observe representative end users completing critical tasks without guidance or support.
5.
Analyze Use Errors
Identify any remaining safety risks, root causes, and task failures impacting submission readiness.
6.
Document Findings for Regulatory Submission
Compile all Human Factors Validation evidence for FDA, MDR, and global notified bodies.
What We Do
Why Work With Human Factor Lab
Our Services
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Summative Usability Validation (Human Factors Validation)
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Regulatory-compliant protocol design (IEC 62366-1 & FDA HFE guidance, NMPA)
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Recruitment of representative clinical user groups
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Critical Task Analysis & risk-based scenario design
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Execution of simulated-use studies in realistic clinical environments
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Complete Human Factors documentation for CE, MDR, NMPA and FDA submissions
Why Work With Us?
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Deep MedTech expertise with decades of clinical and Human Factors experience
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Independent external evaluation — required by FDA and strongly recommended for MDR
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Objectivity that eliminates internal "development blindness" after long project cycles
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Highly efficient testing processes with actionable insights
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Proven success supporting medical device approvals internationally
Everything you want to know
Yes. Medical devices that carry any meaningful use-related risks are expected to undergo Summative Evaluation to meet IEC 62366-1, MDR, and FDA Human Factors requirements. However, the exact need and scope depend on the device’s intended use, risk profile, and user population. Regulators typically require clear evidence that all critical tasks can be performed safely and effectively, and Summative Evaluation is the primary method to demonstrate this.
A common benchmark is around 15 participants per distinct user group, following FDA Human Factors guidance. That said, the precise number can vary depending on the complexity of the device, the variety of user types, and the associated risks of use errors. For some low-risk devices or highly specialized user groups, a smaller or differently structured sample may be appropriate. A Human Factors expert can help define the right sample size based on intended use and risk management expectations.
No. Summative Usability Testing must be conducted with external, representative users who reflect real-world experience and training levels. Internal employees, especially those involved in design or development, introduce bias and are generally not accepted by regulators. Depending on the intended users and environmental conditions, participants may include nurses, surgeons, technicians, home users, or caregivers who accurately represent the device’s real user profile.
