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MDR GAP Analysis Support on Human Factor Engineering- HFE Process

Human Factor Engineering (HFE) is a field of science which revolves around obtaining of information regarding human physiological and psychological characteristics and their application on designing devices and systems for human use.


The EU proposed a new set of regulations regarding medical devices. The requirements were supposed to be implemented from May 2020, but due to recent COVID-19 outbreak, the implementation has been postponed till next year.

New EU MDR and HFE

After implementation of the new MDR, manufacturing companies will ensure that there usability and human factors are up to the required satisfactory level. As new regulations contain more clauses compared to old MDD, the manufacturers will be required to update all their existing medical devices, software and systems as per the new requirements.

HFE and GAP Analysis

New requirements from MDR demand a gap analysis in order for up-gradation of medical devices. This usability-based gap analysis can be assessed by performing a gap analysis.

A gap analysis is an essential part of compliance management. It is performed to highlight the areas in which an organization needs to perform actions so to achieve intended targets. In gap analysis, collection and analysis of previous data is performed after which a report is made that tells about the implementation action plan, so to make organizations compliant with the new requirements, in the case we have the EU MDR for HFE of the medical devices.

Need Consultancy for Your Gap Analysis?

You may face trouble in performing a gap analysis which abides by the requirements of the new MDR. But we, at TS Q & E, won’t let you exhaust your efforts in performing the gap analysis yourself. Since it is a hectic process, and it needs study of EU MDR and then making a check-list out of that and then analyzing the current situation for HFE, ultimately finding the gaps. Its better you focus on business and other management issues and let us serve you in this area.

Our services are available all over the Europe and we are pretty sure that you want to upgrade your HFE processes as per the new MDR. So you can reach us through our contact us form for a free quote.

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