Supporting medical device teams with clinical evidence, human factors, usability engineering and study coordination to demonstrate safe, effective and intended device use.
Clinical Evaluation & Usability evidence must show more than how a device performs technically. DnA helps teams examine how the device is used, what clinical evidence supports it and where further validation or follow-up may be needed across the product lifecycle.
Developing or updating clinical evaluation documentation
Planning human factors and usability engineering activities
Preparing formative or summative usability evaluations
Addressing clinical, PMS or PMCF evidence gaps
Develop and review clinical evaluation evidence around the device’s intended purpose, claims, benefit-risk profile and available clinical data.
Assess users, use environments, critical tasks and use-related risks to support safer device interaction and usability validation.
Plan post-market surveillance and PMCF activities to capture relevant real-world evidence and address remaining clinical questions.
DnA Regulatory Solutions brings clinical evaluation, usability and post-market evidence together rather than treating them as isolated activities. This helps ensure that device claims, identified risks, user interactions and real-world findings remain consistent as new evidence becomes available.
Align clinical conclusions with intended use, claims and risk management
Connect critical tasks and use-related risks with usability validation
Feed PMS and PMCF findings back into clinical and regulatory documentation
Evidence That Continues After Market Entry:
Clinical understanding does not stop once a device reaches the market. Complaints, user feedback, PMCF activities and other post-market information can reveal new evidence that needs to be reflected across clinical, risk and usability documentation.
Clinical evaluation supports conclusions about device safety and performance, while usability engineering examines how intended users interact with the device and associated use-related risks.
Support can include user and use-environment analysis, critical task identification, formative evaluations, summative validation and related IEC 62366 documentation.
Post-market information provides real-world evidence that can reveal new findings and help keep clinical, risk and regulatory documentation current.
Connect clinical findings, user interaction, risk and post-market information to create evidence that reflects how the device performs in practice.