Usability documentation
Ensure your deliverables meet regulatory requirements. We assist clients with preparing the usability engineering file including reports for regulatory authorities.
To satisfy IEC 62366, manufacturers must prepare usability engineering file (UE File) consisting of several deliverables. Further, manufacturers may also need to prepare country-specific reports for regulatory authorities (e.g. the summary HFE/UE report for the FDA and the usability engineering research report for NMPA).
To apply usability and human factors engineering effectively to your medical devices, a Standard Operating Procedure (SOP) should be developed in your organisation to ensure best practice is followed and regulatory requirements are met.
Using in-house templates that have evolved from serving clients globally in the medical device industry, we assist clients with preparing all usability documentation for both new devices in development and marketed devices with a user interface of unknown provenance (UOUP). We can also assist with conducting and documenting the findings of a comparative analysis (threshold analysis).
Our specialist software Usepaq can be used to generate deliverables for the UE file, saving considerable time and effort. We can also perform a gap analysis to determine any missing elements of your existing documentation.