Systems Engineering for Medical Device Development Workshop: Translating customer needs into high-level design inputs and system-level specifications Workshop by Tonex
This workshop provides a comprehensive introduction to the application of systems engineering principles in the medical device development process. The course is specifically tailored for professionals involved in translating customer needs into high-level design inputs and system-level specifications.
Participants will learn tools and techniques for creating best-in-class requirements and ensuring robust requirements traceability throughout the development lifecycle. The focus is on bridging the gap between customer language and technical specifications, a critical aspect of developing safe, effective, and compliant medical devices.
Learning Objectives: By the end of this workshop, participants will be able to:
- Understand the systems engineering approach and its relevance to medical device development.
- Translate customer needs and expectations into clear, actionable high-level design inputs.
- Develop and manage system-level specifications that align with regulatory and quality requirements.
- Utilize tools and methodologies for effective requirements management and traceability.
Integrate risk management principles into the requirements development process. - Ensure that all stakeholders’ needs are reflected in the final product design through comprehensive verification and validation processes.
Target Audience:
- Systems Engineers
- Medical Device Engineers
- Product Managers
- Quality Assurance Professionals
- Regulatory Affairs Specialists
- Design Engineers
- Project Managers
- R&D Engineers
Course Content:
Module 1: Introduction to Systems Engineering in Medical Devices
- Overview of systems engineering principles.
- Importance of systems engineering in the medical device lifecycle.
- Regulatory landscape and standards (e.g., ISO 13485, ISO 14971).
Translating Customer Needs to Design Inputs
- Techniques for eliciting and capturing customer requirements.
- Converting customer language into high-level design inputs.
- Case studies and practical examples.
Developing System-Level Specifications
- Defining system architecture and interfaces.
- Writing clear, concise, and testable requirements.
- Aligning specifications with regulatory requirements and standards.
Tools for Requirements Management and Traceability
- Introduction to requirements management tools and software.
- Creating a requirements traceability matrix (RTM).
- Best practices for maintaining traceability throughout the project lifecycle.
Risk Management in Systems Engineering
- Incorporating risk management into the requirements process.
- Identifying and mitigating risks early in the development cycle.
- Linking risk management activities with design controls.
Verification and Validation (V&V)
- Developing V&V strategies to ensure design meets requirements.
- Traceability from requirements to V&V activities.
- Documenting and managing V&V results to ensure compliance.
Case Studies and Hands-on Exercises
- Real-world examples of systems engineering in medical device development using MBSE/SysML.
- Group exercises in translating customer needs to systems requirements and design inputs.
- Developing and managing system-level specifications.
Certification Exam:
At the conclusion of the workshop, participants will have the option to take a certification exam. The exam will assess participants’ understanding of the course material, including the ability to translate customer needs into design inputs, develop system-level specifications, and manage requirements traceability.
Upon successful completion, participants will be awarded a certificate recognizing their expertise in systems engineering for medical device development.