Module 14: Design Development and Certification of Medical Devices

What is the Human Factors and Usability Engineering process?

The Human Factors Engineering and Usability Engineering processes vary dependent on the regulation compliance is required for. Very subtly. The differences are small but all have the same outcome: mitigation and evidence to support a rationale of use safety, to ensure the clinical benefit of the drug device combination product outweighs the inherent risks of use.

All standards link to ISO 14971 (2012) and not the 2019 version since it has recently been revised.

All processes follow the same route – INPUTS, PROCESS and OUTPUTS.

Source: Human Factors and Usability Engineering – Guidance for medical devices including drug device combination products . The MHRA Human Factors and Usability method.

The Organisation for Professionals in Regulatory Affairs

Human Factors and Usability Testing during development