medical device testing

Read our viewpoint article on The Importance of Human Factors Validation Testing for New Medical Devices to learn the points you should consider when selecting a vendor.

medical device usability testing
“UX Firm has been a great partner to help us prepare the Usability study for our FDA submission. They have helped us in all the steps of the process, always open for discussion and giving great feedback on our product and its testing. I’m very happy that we trusted in UX Firm and I’m sure we will continue to do so in our future developments.”
Borja Gonzalvez

Product Manager, Nuubo

Recent Satisfied Clients

Usability Testing of Medical Devices

Medical device human factors validation testing requires strict procedures following the Guidelines issued by FDA and IEC to validate the safe and effective use of medical devices. UX Firm has a proven track record of delivering effective test protocols for FDA review, high quality formative and summative usability evaluations, and highly detailed reports to be used in FDA pre-market submissions for 510(k) and De Novo classifications. We also follow European MDR requirements and provide research that supports CE marking.

The big companies charge very big bucks for these services. Because we are a boutique consultancy, we can be highly competitive in pricing and highly effective in working directly with you to produce the research results you require.

UX Firm Named in Top 10 Medical Device Testing and Certification Companies for 2019

UX Firm is now part of the honored group of companies listed on MedTech Outlook’s Platform – Medical Device Testing and Certification Companies, 2019.  MedTech Outlook did a great profile of UX Firm.

Read our 2021 predictions for trends in medical device usability testing.

IEC 62366, ISO 14971, & ANSI/AAMI HE75 Require Human Factors Usability Testing


IEC 62366

“IEC 62366 specifies a process for a manufacturer to analyze, specify, develop, and validate the usability of a medical device as it relates to safety. . . . Part 1 has been updated to include contemporary concepts of usability engineering, while also streamlining the process.

It strengthens links to ISO 14971. . . . Part 2 [offers] more detailed descriptions of usability engineering methods that can be applied generally to medical devices.”

ANSI/AAMI HE75 Human Factors Engineering—Design of Medical Devices

provides comprehensive guidance on designing to accommodate user characteristics, managing the risk of use error, and undergoing usability testing to confirm the safety and effectiveness of the design. This document complements ANSI/AAMI/IEC 62366.


FDA issues guidance for Applying Human Factors and Usability Engineering to Medical Devices

The most recent guidance was issued on February 3, 2016.

“FDA has developed this guidance document to assist industry in following appropriate human factors and usability engineering processes to maximize the likelihood that new medical devices will be safe and effective for the intended users, uses and use environments.”

UX Firm ensures compliance in Medical Device Human Factors Validation Testing

UX Firm provides our team of highly qualified, experienced researchers to conduct formative and summative usability testing of medical devices. Our processes ensure compliance with all regulations and guidelines in support of successful  FDA 510(k) submissions.

applying human factors and usability engineering

Requirements Gathering

  • Engage with stakeholders
  • Determine goals for product
  • Gather requirements from known sources
usability engineering for medical devices

Preliminary Analysis

  • Conduct heuristic evaluation/expert review
  • Review  critical risk factors
  • Determine target user groups
  • Identify tasks for testing
formative usability testing

Formative Usability Testing

  • Engage with stakeholders to plan the study
  • Determine users, tasks, environments
  • Establish critical risk factors
  • Conduct testing and analysis
  • Recommend changes
human factors validation testing

Human Factors Validation Testing

  • Plan study/develop test protocol
  • Use uFMEA to identify critical risk factors
  • Conduct testing to determine root causes of errors
  • Prepare formal report of findings
For every phase of your planning and development process for medical device usability testing, we provide the right set of tools from our UX toolkit to gain insights into your users’ goals and context of use, building knowledge of user experience into all stages of product development from requirements gathering to the documentation of findings and recommendations against established criteria of safety, ease of use, and effectiveness of the design.

As part of our engagement with clients, we can do any or all of the following tasks:

  • Write the test plan
  • Prepare IRB approval documents (when required)
  • Manage participant recruitment
  • Conduct formative and summative/human factors testing
  • Write a comprehensive report to include root cause analysis of errors

Related Medical Device Usability Testing Resources

In person usability testing during COVID-19.  Yes, we can!

In person usability testing during COVID-19. Yes, we can!

Can you do in-person usability testing safely in a COVID world?  You betcha!  I have just completed my second study and have the next one coming up soon.  Let me tell you how I did it. Testing in a COVID-protected usability lab Before COVID-19, I would often conduct...

Case Study Example

Study Goals

Gain insights into user experience of multiple product design prototypes to determine preferences, success/failure rates, and safety of use by caregiver, clinician, and patient populations.


Structure a comparative usability evaluation of five prototypes with representative users from three population groups, using all versions of the prototype (in varied order) to determine human factors issues, including safety and reliability, as measured against a specific set of criteria.


A sample page from the report shows the results of one aspect of this testing. Two prototypes were determined to be the most successful and acceptable to the three user groups, with features from a third prototype reflecting some interest and acceptance from study participants. Recommendation was accepted to continue design and development of two prototypes to include the best features identified from this evaluation.

Retest took place in an iterative design process to determine improvements in success/acceptance in usability testing of more advanced models.

case study data

Client Response

[Our company] engaged UX Firm to conduct usability testing on our product in development. The study involved numerous concepts with different user groups and environments. UX Firm did an outstanding job conducting the study and analyzing the results in a timely fashion. They made relevant suggestions for device and labeling design changes to enhance user experience and safety. Their final presentation and report was professional and thorough.

–Human Factors Evaluation Leader, R&D