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 design inputs to validation, supporting a structured development process.

KU/KTs

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

• Requirements – Define what needs to be achieved, often derived from risk control measures.
• Design Input – Specifications and constraints derived from requirements to guide development.
• Design Output – The result of the design process, generated from design inputs.
• Verification – Ensures that requirements and design outputs meet specified criteria.
• Risk Control Measures – Actions or processes implemented to reduce risk, often basis for requirements.
• Validation – Confirms that the final system or product meets user needs and intended use.

Defining Relationships in Risk Analysis

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
Requirements	Derived from	Risk Control Measures	No	Select the risk control measure that led to this requirement.
	Implements	Risk Control Measures	Yes	Select the risk control measures this requirement implements.
	Derived	Design Input	Yes	Select design inputs derived from this requirement.
	Verification Tests	Verification	Yes	Select verification activities linked to this requirement.
	Validation Activities	Validation	Yes	Select validation activities linked to this requirement.
Design Input	Derived from	Requirements	No	Select the requirement that led to this design input.
	Results in	Design Output	Yes	Select the design outputs derived from this input.
Design Output	Generated from	Design Input	No	Select the design input leading to this output.
	Verified By	Verification	Yes	Select verification activities ensuring compliance.
Verification	Verifies	Requirements	No	Select the requirement verified by this activity.
	Verifies	Design Output	Yes	Select design outputs verified by this activity.
Risk Control Measures	Implemented By	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	Requirements	No	Select the requirement validated by this activity.

Concrete Example

A specific identified Requirement is saved like this:

This, for example, is a concrete instance that can have a relationship to a specific Risk Contorl Measure, Design Input, Verification and Validation instance.

Templates & Forms

The Requirements Engineering use case includes essential templates to help structure and document the development process effectively:

• Requirements List – Captures and tracks all device requirements, ensuring clear traceability.
• Device Design Plan – Outlines the design and development approach, including key milestones and responsibilities.

These templates ensure a well-organized and compliant requirements engineering process.

SOPs

Rquirements 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

The Risk Management use case connects with the Risk Management use case through Risk Control Measures.

This connection is established by including the Risk Control Measure knowledge topic (KT) in both use cases.

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.