All pathsR&D · Human Factors · QA · 9 terms

Risk & Usability Deep Dive

Name: Risk & Usability Deep Dive
Availability: InStock

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

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.
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.
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.
4

Standards

IEC 62366-1

Application of usability engineering to medical devices.

Why this term here: The lifecycle process for usability engineering.
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.
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.
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.
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.
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.

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

Take the Risk & Usability Deep Dive quiz

Risk & Usability Deep Dive

ISO 14971

Risk Management File(RMF)

Risk Acceptability Matrix

IEC 62366-1

Human Factors Engineering(HFE)

Use Specification

Use Error

Summative vs. Formative Evaluation

Labeling