Requirements Management Use Case

In medical device development, maintaining clear traceability from initial requirements through design and verification is crucial for regulatory compliance. The Requirements Management Use Case helps you maintain compliance with ISO 13485 and FDA QSR standards by providing a structured approach to requirements management.

How Requirements Management Works

The Requirements Engineering Use Case provides a systematic approach to capturing, managing, and verifying requirements for your medical device. It ensures compliance with regulatory standards while maintaining clear traceability from user requirements through design output to verification and validation, supporting a structured development process.

KU/KTs

The Requirements Engineering use case in CertHub includes the following key components:

Required Knowledge Topics:

• User Requirements – The needs and expectations of the end-users.
• System Requirements – The functional and non-functional requirements for the entire system.
• Design Output – The result of the design process that implements the requirements.
• Verification – Ensures that requirements and design outputs meet specified criteria.
• Validation – Confirms that the final system or product meets user needs and intended use.
• Risk Control Measures – Actions or processes implemented to reduce risk, often basis for requirements.

Optional Knowledge Topics:

• Component Requirements – Requirements for an individual component, derived from system requirements.
• Unit Requirements – Requirements for an individual unit, derived from component requirements.
• Hardware Requirements – Requirements for the hardware of the device, derived from system requirements.
• Use Scenarios – Descriptions of how the device is used, from which requirements are derived.

Defining Relationships in Requirements Management

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 Knowledge Topic (KT) can have different relationships defined within the use case configuration.

Source Knowledge Topic	Relation Name	Target Knowledge Topic	Allow Multiple	Description
User Requirements	Relates to	Risk Control Measures	Yes	Select the risk control measure that are related to this requirement.
	Derived from	Use Scenarios	Yes	Select the use scenario that led to this requirement.
	Validated By	Validation	Yes	Select validation activities linked to this requirement.
	Leads to	System Requirements	Yes	Select system requirements that were derived from this user requirement.
System Requirements	Derived from User Requirement	User Requirements	Yes	Select the user requirement that led to this system requirement.
	Derived from Use Scenario	Use Scenarios	Yes	Select the use scenario that led to this requirement.
	Derived from RCM	Risk Control Measures	Yes	Select the risk control measure that led to this requirement.
	Results in	Component Requirements	Yes	Select the component requirements that were derived from this system requirement.
	Verified By	Verification	Yes	Select verification activities linked to this requirement.
Hardware Requirements	Derived from	System Requirements	Yes	Select the system requirements that led to this hardware requirement.
	Results in	Component Requirements	Yes	Select the component requirements that were derived from this hardware requirement.
Component Requirements	Derived from	System Requirements	Yes	Select the system requirements that led to this component requirement.
	Derived from *	Hardware Requirements	Yes	Select the hardware requirements that led to this component requirement.
	Related to	Risk Control Measures	Yes	Select the risk control measure that led to this requirement.
	Results in	Unit Requirements	Yes	Select the unit requirements that were derived from this component requirement.
	Verified by	Verification	Yes	Select the verification activities that verified this component requirement.
Unit Requirements	Derived from Component Requirements	Component Requirements	Yes	Select the component requirements that led to this unit requirement.
	Derived from RCM	Risk Control Measures	Yes	Select the risk control measure that led to this requirement.
	Verified By	Verification	Yes	Select the verification activities that verified this unit requirement.
Design Output	Relates to SR	System Requirements	Yes	Select the system requirements that are related to this design output.
	Relates to CR	Component Requirements	Yes	Select the component requirements that are related to this design output.
	Relates to UR	Unit Requirements	Yes	Select the unit requirements that are related to this design output.
	Verified By	Verification	Yes	Select verification activities ensuring compliance.
	Validated By	Validation	Yes	Select validation activities ensuring compliance.
	Related to HWR *	Hardware Requirements	Yes	Select the hardware requirements that are related to this design output.
Verification	Verifies SR	System Requirements	Yes	Select the system requirements verified by this activity.
	Verifies CR	Component Requirements	Yes	Select the component requirements verified by this activity.
	Verifies UR	Unit Requirements	Yes	Select the unit requirements verified by this activity.
	Verifies DO	Design Output	Yes	Select design outputs verified by this activity.
Risk Control Measures	Implemented By	System Requirements	Yes	Select requirements that implement this control measure.
	Verified By	Verification	Yes	Select verification activities ensuring control measure effectiveness.
	Validated By	Validation	Yes	Select validation activities confirming control measure suitability.
Validation	Validates	User Requirements	Yes	Select the user requirement validated by this activity.
	Validates DO	Design Output	Yes	Select design outputs validated by this activity.
Use Scenarios	Related User Requirement	User Requirements	Yes	Select the user requirements related to this use scenario.
	Related System Requirement	System Requirements	Yes	Select the system requirements related to this use scenario.

* The relations from Component Requirements and Design Output to Hardware Requirements are only available if your product contains the Hardware Requirements Knowledge Topic.

All relations listed above are bidirectional: creating a link on one side automatically makes it visible on the related Knowledge Topic as well.

Concrete Example

A specific identified User Requirement is saved like this:

This, for example, is a concrete instance that can have a relationship to a specific Risk Control Measure, Use Scenario, Validation and System Requirement instance.

SOPs

Requirements Engineering in CertHub follows a structured process:

1. 🔍 Device Control Process – Defines how requirements are managed throughout the device lifecycle, ensuring compliance and safety.

Regulatory Compliance

The Requirements Management Use Case helps satisfy key regulatory requirements:

• ✅ ISO 13485:7.3 Design and Development
• ✅ FDA 21 CFR 820.30 Design Controls
• ✅ EU MDR Article 10 General Obligations

By following the structured approach provided by this Use Case, you can demonstrate complete requirements traceability during regulatory audits.

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:

• Active Device – Risk Control Measures
• Essential Performance – System Requirements, Verification
• General Use Case – User Requirements
• Risk Management – Risk Control Measures, Verification
• Software Engineering – System Requirements, Design Output, Risk Control Measures
• Summative Evaluation – Use Scenarios
• Usability Engineering – Use Scenarios

By reusing shared KTs, CertHub makes integrating different use cases seamless and efficient, ensuring smooth traceability across processes.

Have a look at the Risk Management Use Case for more information on how the Risk Control Measure is used.