General Use Case
The General Use Case contains relations between general product data that are not specific to one regulatory area, such as Variants/Configurations, Device Labels, Target Markets and Parts/Components. It has no required Knowledge Topics, so it never shows a use case status banner: each relation is available as soon as both of its Knowledge Topics exist.
Knowledge Topics
All Knowledge Topics of this use case are optional:
- Device Label(s)
- Variants/Configurations
- Technical Specifications
- Target Markets
- User Profiles
- User Requirements
- Target Markets Metadata
- Parts/Components
- Raw Materials
Relationships
The diagram shows how the Knowledge Topics of this use case are connected. An arrow points from the source to the target Knowledge Topic. An arrow with two arrowheads marks a bidirectional relationship.
Each row is one trace column on the source Knowledge Topic. Allow Multiple shows whether a record can be linked to more than one target record. Bidirectional relations are also shown on the target Knowledge Topic.
| Source Knowledge Topic | Relation Name | Target Knowledge Topic | Allow Multiple | Bidirectional | Description | Additional Fields |
|---|---|---|---|---|---|---|
| Device Label(s) | Relates to | Variants/Configurations | Yes | Yes | Select the Variants/Configurations that are related to this Device Label. | |
| Variants/Configurations | Relates to | Device Label(s) | Yes | Yes | Select the Device Label(s) that are related to this Variant/Configuration. | |
| Relates to | Technical Specifications | Yes | Yes | Select the Technical Specifications that are related to this Variant/Configuration. | ||
| Sold in | Target Markets | Yes | Yes | Select the Target Markets where this Variant/Configuration is sold. | ||
| Relates to | Target Markets Metadata | Yes | Yes | Select the Target Markets Metadata that are related to this Variant/Configuration. | ||
| Technical Specifications | Relates to | Variants/Configurations | Yes | Yes | Select the Variants/Configurations that are related to this Technical Specification. | |
| Target Markets | Selling here | Variants/Configurations | Yes | Yes | Select the Variants/Configurations that are sold in this Target Market. | |
| Relates to | Target Markets Metadata | Yes | Yes | Select the Target Markets Metadata that are related to this Target Market. | ||
| User Profiles | Has Requirements | User Requirements | Yes | Yes | Select the User Requirements that are related to this User Profile. | |
| User Requirements | Applies to | User Profiles | Yes | Yes | Select the User Profiles that are related to this User Requirement. | |
| Target Markets Metadata | Relates to | Target Markets | Yes | Yes | Select the Target Markets that are related to this Target Markets Metadata. | |
| Relates to | Variants/Configurations | Yes | Yes | Select the Variants/Configurations that are related to this Target Markets Metadata. | ||
| Parts/Components | Composed of | Raw Materials | Yes | Yes | Select the Raw Materials that this Part/Component is composed of. | |
| Raw Materials | Linked Part/Component | Parts/Components | Yes | Yes | Select the Parts/Components that this Raw Material is used in. | Component |
Additional Fields are extra columns that show a field of the linked record, such as the component of a linked Part/Component.
Integration with Other Use Cases
Knowledge Topics that belong to more than one use case connect those use cases. This use case shares Knowledge Topics with:
- Biocompatibility – Parts/Components
- Formative Evaluation – User Profiles
- Post-Market Surveillance – Target Markets
- Requirements – User Requirements
- Risk Management – Parts/Components
- Software Engineering – Parts/Components
- Sterile – Parts/Components
- Summative Evaluation – User Profiles
- UDI Management – Device Label(s), Variants/Configurations
- Usability Engineering – User Profiles