Ensure your deliverables meet regulatory requirements. We assist clients with preparing the usability engineering file and HFE reports for FDA marketing submissions.
To satisfy IEC 62366-1:2015+AMD1:2020, manufacturers must prepare a Usability Engineering file consisting of several deliverables. For FDA premarket submissions in the United States, manufacturers should also prepare a summary HFE report.
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 over 13 years, we assist clients with preparing all forms of usability documentation for both new devices in development and marketed devices with a User Interface of Unknown Provenance (UOUP).
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.
