Modern Requirements Analysis for the Medical Device Industry
Two-Day Applied Course
Whether in the automotive, aerospace, or medical device industry—can a product or system succeed today without applying modern systems engineering principles? Hardly. To ensure that the technical solution of a medical device sustainably meets customer needs, effective requirements engineering (RE) is essential.
To prevent tools from dictating the process—instead of following it—it is crucial to define, manage, and implement well-structured and technically sound requirements. Each requirement should be specified in alignment with a clearly defined system architecture.
Ultimately, the requirements must be verified by a set of test cases, providing the objective evidence necessary for successful regulatory approval and market access in international markets.
In this interactive seminar, you will learn how to improve your requirements analysis through precise language techniques, how to adapt the process to your specific project environment, and how to establish a solid foundation for the success of your products.
- Content
- Fundamentals of Requirements Engineering
- Key characteristics and definitions
- Scope and domains of application
- Using requirement sentence templates for consistency
- Examples from the “RE poison cabinet” (typical pitfalls)
- Interplay of Requirements Engineering and System Elements
- Use cases and product backlogs
- System architecture modeling (SysML)
- Blocks, ports, and connectors
- Integrating requirements as model elements
- Verification and Validation of Requirements
- Lifecycle management
- Assessing testability of requirements
- Developing test cases and test runs
- Best practices for formulating effective test cases
- Tool-Supported Requirements Engineering for Medical Devices
- Traceability and suspect link management
- RE tools and requirements exchange mechanisms
- Creation and linking of requirements and test cases
- Version control and report generation
- Fundamentals of Requirements Engineering
- Your Benefits
- Learn how to identify and implement requirements engineering principles and best practices.
- Understand how requirements engineering, system architecture, and verification/validation interact within both traditional and agile development models.
- Gain hands-on experience with a sample toolchain for requirements capture and management.
- Obtain practical, industry-oriented solutions for your organization.
- Explore various elicitation techniques for identifying and refining requirements.
- Learn to adapt the requirements analysis process to your specific project environment.
- Methods
Presentation, workshops, real-life examples, discussion, storytelling
- Target Audience
- Manufacturers of medical devices and in vitro diagnostic devices
- System analysts
- Regulatory affairs managers
- Quality management representatives
- Application developers
- Requirements engineers
- Systems engineers
- Project managers
- IT project team members
- Professionals from related industries such as automotive, aviation, and general manufacturing
