Modern Requirements Analysis for Medical Technology
Whether in the automotive industry, aviation or medical technology – can a product or system survive in todays world without the application of modern systems engineering? Hardly. To ensure that the technical solution for a medical device consistently meets customer needs, effective requirements engineering is essential.
To ensure that applications do not dictate the process but rather follow a defined process, it is important to create, manage, and successfully implement technically sound requirements. To this end, each requirement should be specified against a clearly defined system architecture.
Finally, the requirements must be verified through a set of test cases so that the necessary evidence can be provided for the product or system in question, enabling successful approval in international markets.
In this interactive seminar, you will learn which linguistic tools can improve your requirements analysis, how to adapt the process to the given project environment and thus lay an important foundation for the success of your products.
- Content
- Fundamentals of Requirements Engineering
- Characteristics and Definitions
- Scopes and Domains
- Support Using Sentence Templates
- Examples from the RE “Toxic Cabinet”
- Requirements Engineering and System Elements in Interaction
- Use Cases and Backlogs
- Modeling a System Architecture (SysML)
- Blocks, Ports, and Connectors
- Requirements as a Model Component
- Verification and Validation of Requirements
- Life Cycle
- Testability of Requirements
- Test Cases and Test Runs
- Effective Formulation of Test Cases
- Tool-Supported Requirements Engineering Using the Example of a Medical Device
- Traceability and Suspects
- RE Tools and Exchange of Requirements
- Creating and Linking Requirements and Test Cases
- Version Management and Report Generation
- Your Benefits
- You will learn about the various requirements of requirements engineering and how to implement them.
- You will discover how the domains of requirements engineering, system architecture, and verification/validation are interconnected within process models (traditional or agile).
- You will learn how to use a sample toolchain for capturing requirements.
- You will receive practical solutions for your company.
- You will learn about the various requirements elicitation techniques available.
- You will be able to adapt the requirements analysis process to the specific project environment.
- Methods
Instructor-led sessions, group exercises, facilitated case studies, practical exercises, individual work, real-world case studies, discussions, live coaching, storytelling.
- Target Audience
- Manufacturers of medical devices and in vitro diagnostic devices
- Systems analysts
- Regulatory affairs managers
- Quality management representatives
- Application developers
- Requirements engineers
- Systems engineers
- Project managers
- Project staff in the IT sector
- Other industries such as automotive, aviation, or general manufacturing
