---
title: "Risk & Usability Deep Dive - Learning Path - MedTech Terms"
description: "ISO 14971 risk management paired with IEC 62366-1 usability engineering, the two lifecycle standards regulators expect on every device."
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[All paths](/paths)R&D · Human Factors · QA · 9 terms 

# Risk & Usability Deep Dive

ISO 14971 risk management paired with IEC 62366-1 usability engineering, the two lifecycle standards regulators expect on every device.

Your progress

0 of 9 lessons complete · up next: ISO 14971 

[Start path](/terms/iso-14971?from=risk-and-usability)

1.  1
    
    [
    
    Standards
    
    ## ISO 14971
    
    International standard for the application of risk management to medical devices.
    
    Why this term here: The foundation. Everything else in this path connects back to it.
    
    ](/terms/iso-14971?from=risk-and-usability)Mark done
    
2.  2
    
    [
    
    Quality & Risk
    
    ## Risk Management File(RMF) 
    
    Set of records and outputs from the ISO 14971 risk management process.
    
    Why this term here: The living compilation regulators inspect first when they arrive.
    
    ](/terms/risk-management-file?from=risk-and-usability)Mark done
    
3.  3
    
    [
    
    Quality & Risk
    
    ## Risk Acceptability Matrix
    
    Pre-defined matrix mapping severity × probability combinations to acceptable, ALARP, or unacceptable risk.
    
    Why this term here: Your policy on what risk you will and will not tolerate.
    
    ](/terms/risk-acceptability-matrix?from=risk-and-usability)Mark done
    
4.  4
    
    [
    
    Standards
    
    ## IEC 62366-1
    
    Application of usability engineering to medical devices.
    
    Why this term here: The lifecycle process for usability engineering.
    
    ](/terms/iec-62366-1?from=risk-and-usability)Mark done
    
5.  5
    
    [
    
    Clinical & Trials
    
    ## Human Factors Engineering(HFE) 
    
    Engineering discipline focused on safe and effective device use by intended users.
    
    Why this term here: FDA's parallel expectation set for user-interface risk.
    
    ](/terms/human-factors?from=risk-and-usability)Mark done
    
6.  6
    
    [
    
    Quality & Risk
    
    ## Use Specification
    
    Defined description of intended users, uses, use environments, and patient populations for a device.
    
    Why this term here: The written scope of intended users, uses, and environments.
    
    ](/terms/use-specification?from=risk-and-usability)Mark done
    
7.  7
    
    [
    
    Clinical & Trials
    
    ## Use Error
    
    User action or lack thereof that leads to a different result than intended by the manufacturer or expected by the user.
    
    Why this term here: How the standard defines use-related risks distinct from misuse.
    
    ](/terms/use-error?from=risk-and-usability)Mark done
    
8.  8
    
    [
    
    Quality & Risk
    
    ## Summative vs. Formative Evaluation
    
    Iterative usability studies (formative) vs. final validation testing (summative) of a device's user interface.
    
    Why this term here: The two study types and where each belongs in the design cycle.
    
    ](/terms/summative-formative?from=risk-and-usability)Mark done
    
9.  9
    
    [
    
    Regulatory
    
    ## Labeling
    
    All written, printed, or graphic matter on or accompanying a device.
    
    Why this term here: The final risk control most teams underestimate.
    
    ](/terms/labeling?from=risk-and-usability)Mark done
    

Finished the path? Test yourself with a quiz tailored to these 9 terms.

[Take the Risk & Usability Deep Dive quiz](/quiz?path=risk-and-usability)

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Resources

-   [FDA Medical Devices](https://www.fda.gov/medical-devices)
-   [EU MDR](https://eur-lex.europa.eu/eli/reg/2017/745/oj)
-   [IMDRF](https://www.imdrf.org/)
-   [Methodology](/methodology)
-   [Changelog](/changelog)
-   [Editor: Christian Espinosa](/authors/christian-espinosa)
-   [About this site](/about)

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