Human Factors Engineering

Website https://compliance2go.com/product/?pid=CP2014-351 | Edit Freely

Category Medical Device

Deadline: September 15, 2014 | Date: September 15, 2014

Venue/Country: online, U.S.A

Updated: 2014-08-27 16:58:02 (GMT+9)

Call For Papers - CFP

Usability Engineering, (Human Factors Engineering) is an essential part of a device development program. In fact, a major issue arises when a device works correctly, but is used incorrectly. This is called “use error” and can cause harm to a patient or user.

If you have not implemented a Usability Engineering program, your design control system is not adequate. You open yourself up to audits, inspections, and product liability issues. The program will help you ensure your devices are used correctly and that ISO 14971:2007 risk reduction using information for safety is effective.

The solution is to implement IEC 62366:2007 which explains how to create a Usability Engineering program. This international standard is recognised by FDA-CDRH and harmonized to the MDD. In addition, FDA-CDRH has a draft guidance that explains their approach, which aligns with IEC 62366.