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Medical Device Usability

Medical Device Usability Testing

Medical device usability testing is also known as human factors engineering. This is the application of information about human behavior, capabilities, shortcomings, and other features to the design of medical devices like software, systems, tasks to achieve adequate usability.


Three major elements of medical device usability is User Interface, and Use Environment. The interaction of these 3 elements with device in Use results in either safe and effective use or correct use or unsafe or ineffective use or user error.


Usability Testing of medical devices is the characteristics of the User Interface that facilitate Use, to make it easier for the users to perceive the information presented by the User Interface, to understand and make a decision based on that information.


To interact with the medical device to achieve specified goals in the intended use environment. These factors can influence safety to various degrees. Usability Testing of medical devices refers to the user interface characteristic which establishes user learning and user satisfaction, effectiveness, efficiency, and ease.

Medical Device Usability Process

It is a process which provides safety for the patient, user and others related to medical device usability. This process mitigates the risks associated with the correct use and use errors due to usability problems. This process helps manufacturer to:

  • Identify hazards and hazardous situations related to the user and user interface
  • Design and implement risk control measures related to the user interface
  • Evaluate the risk control measures

 The process is as follows:

  1. Prepare use specification,
  2.  Identify frequently used functions,
  3.  Identify known or foreseeable hazards and hazardous situation (ISO 14971-foreseeable misuse)
  4.  Identify device primary operating function,
  5.  Develop Usability specification,
  6.  Prepare usability validation plan,
  7.  Design and implement user interface,
  8.  Verify user interface,
  9.  Validate usability of medical device

Usability Engineering Medical Devices

All aspects of medical device usability should be documented in a usability engineering file. It should have the following aspects:

  • Independent file
  • Part of product design file or risk management file
  • Should contain references and pointers to all required documents
  • Should enable efficient auditing of the design and development process

Medical Device Usability standards and per EU MDR

US FDA Approval
As per the Annex I of EU MDR 2017/745, the Usability requirements are mentioned in the following GSPRs: 5, 14.2, 14.6.

The latest EU harmonized standard for medical device usability is EN 62366:2008, Medical Devices: Application of Usability Engineering Medical Devices. This is a process-based standard for usability analysis, design, verification, and validation through the medical device development cycle as it relates to their safety.


This is an adopted standard from the international standard IEC 62366:2007.

There is a collateral standard for Medical Electrical Equipment which is IEC 60601-1-6:2010 harmonized to EN 60601-1-6:2010.  Clauses 7.3.3(a) and Cl. 7.3.9 states about usability in EN ISO 13485:2016 Quality Management System.

Importance of Medical Device Usability

US FDA Approval

It reduces the use error, reduces the training efforts needed, improves performance in using devices, reduces stress of the user. It should be conducted throughout all phases of design and development of medical devices.