Total Compliance™ Solutions
Our Total Compliance™ Solutions support medical device manufacturers throughout the regulatory journey, helping ensure usability, labelling, and human factors evidence meets the expectations of global regulators, including FDA, MDR, and IVDR.
We work closely with your regulatory, engineering, and quality teams to generate clear, defensible evidence that stands up to scrutiny.
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Readability Studies
Readability studies assess whether users can find, understand, and correctly interpret critical information in patient-facing materials such as Instructions for Use (IFUs), Patient Information Leaflets (PILs), labels, and packaging.
These studies are often required to demonstrate compliance with regulatory guidance and standards, and to reduce the risk of use errors caused by misunderstanding.
What we do:
Test comprehension of key safety and use information with representative users
Identify areas of confusion, misinterpretation, or ambiguity
Provide clear evidence of readability and understanding
Support updates and re-testing where required
Readability studies are suitable for both early development and submission-ready documentation.
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Human Factors Validation Tests
Human Factors Validation Tests (also known as summative usability studies) are designed to confirm that intended users can safely and effectively use a medical device in realistic conditions.
These studies are a critical requirement for regulatory submissions in many markets, including the USA and EU.
What we do:
Design and conduct risk-based validation studies aligned with regulatory expectations
Recruit representative users (e.g. patients, healthcare professionals, caregivers)
Evaluate critical tasks and use scenarios
Identify and document use-related risks and mitigations
Produce clear, regulator-ready reports
Our approach focuses on demonstrating safety and usability, not just identifying problems.
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MDR / IVDR Compliance (IEC 62366-1 Annex C)
For products regulated under EU MDR or IVDR, we provide structured support aligned with IEC 62366-1 Annex C, ensuring human factors and usability engineering activities are clearly documented and compliant.
This service is ideal for manufacturers preparing for EU submissions or addressing notified body feedback.
What we do:
Support usability engineering activities required under MDR / IVDR
Align usability evidence with Annex C expectations
Review existing documentation and identify gaps
Provide structured, defensible outputs suitable for technical files
Support both new submissions and remediation projects
We focus on clarity, traceability, and regulatory confidence.
