On this page
- Choose the published European base
- Safety-related usability is a defined subject
- Compare usability services by the actual assignment
- Questions before commissioning a study
- Example: revising a device setup screen
- Connect usability evidence to device decisions
- Frequently asked buying questions
- Related guidance
- Explore more standards buying guides
Choose the published European base
Safety-related usability is a defined subject
The public scope describes analysing, specifying, developing and evaluating medical-device usability as it relates to safety. It addresses correct use and use errors in normal use. It can identify abnormal-use risks but does not assess or mitigate them within this process.
For procurement, explain who will use the device, the intended use environment and the tasks under consideration. Ask the provider what information it needs to propose an appropriate assignment. A general request to “test the interface” leaves important scope decisions unresolved.
Compare usability services by the actual assignment
| Briefing element | Question to settle |
|---|---|
| Device and interface | Which design version and supplied information are included? |
| User and task context | Which intended users, environments and tasks form the study brief? |
| Engineering deliverable | Is the offer for planning, a specific study, review or a wider service? |
| Evidence handover | What conclusions and limitations will be passed to the device team? |
The table is an original purchasing aid. It does not prescribe participants, sample sizes, study methods or acceptance criteria. Those decisions need a device-specific technical proposal and review by the responsible team.
Questions before commissioning a study
- Does the proposal identify the same intended-user and task context as the buyer?
- What device version and accompanying information must be supplied?
- Which planning and preparation activities are included in the price?
- How will limitations and unresolved questions appear in the deliverable?
- Who reviews the consequences of a design or information change after the study?
Compare offers using a shared brief rather than a participant count alone. Providers may include different preparation, analysis and reporting work. Ask how their deliverables will support the manufacturer's actual engineering decisions.
Example: revising a device setup screen
A medical-device manufacturer plans to revise a setup screen. It requests two usability service quotations, but one provider assumes a finished device while another proposes early design work. The buyer supplies the interface baseline, intended users and tasks, then asks each provider to state the work and evidence included.
The final order identifies the design version, supplied instructions and review responsibilities. It also explains how findings will reach the design and risk-management teams. The example does not establish that the interface is suitable; it demonstrates how the buying brief can make study proposals comparable.
Connect usability evidence to device decisions
Use the same device and design identifiers across usability and other evidence packages. A study about one screen arrangement should retain that identity when the design changes. Ask the technical team to explain which conclusions remain usable and which questions require further work.
Give risk management, software development and device release their own responsible owners. The usability provider can deliver information to those assignments, but the contract should not leave their scope implied. Retain the agreed input and output list with the project record.
Frequently asked buying questions
Is this a general customer-satisfaction document?
The verified scope concerns usability as it relates to medical-device safety. Define broader user-experience work separately if it is also needed.
Does one study complete every usability assignment?
Compare its actual scope with the engineering work the device team needs. A study report should identify the version, context and limitations it addresses.
Does the base purchase include the amendment?
Genorma lists a separate amendment product. Confirm the supplied package and correction information instead of assuming consolidation.
Related guidance
Continue with medical risk management buying and medical software contracting.
Explore more standards buying guides
Browse standards by reference and subject to compare related document choices.