Usability Engineering File
for medical devices and IVD Vitro Diagnostics
Manufacturers marketing medical devices need to be able to demonstrate compliance with the usability requirements introduced by regulatory requirements.
for medical devices and IVD Vitro Diagnostics
Manufacturers marketing medical devices need to be able to demonstrate compliance with the usability requirements introduced by regulatory requirements.
Clause 5 of EN 62366, Usability Engineering Process, describes the steps in the process. As the standard points out in Clause 4.3.
Scaling of the usability engineering effort, they can vary in form and extent, depending on the nature of the medical device, its intended user and its intended use. In addition, the standard advises that, because of the iterative nature of the usability engineering process, the activities described in Clause 5 can be performed in any convenient order.
Briefly stated, however, the usability engineering process includes the following steps:
The results of the usability engineering process should be recorded in the usability engineering file; however, if the records and documents are part of other documents and files, the usability engineering file can refer to the location of these records and documents.
In many cases, the most efficient and cost-effective method of obtaining usability data is to collect these data during a premarket clinical investigation that is being conducted to establish safety and performance as part of device validation. This approach has the advantage of reducing the number of studies needed and also avoiding potential problems in determining ethical and regulatory requirements applicable to the usability aspects of the study.
GemarMed’s regulatory, quality assurance and Design Control expertise and experience allow us to offer our services to meet Usability Requirements. Given the necessary accessibility to device and users profile and other required resources, companies may capitalize on our long-standing and proven track record in successfully designing usability engineering activities, applied to the various steps of V&V of medical devices development.