Best Practices in Agile Software Development for Class 3 Medical Devices Training by Tonex
Best Practices in Agile Software Development for Class 3 Medical Devices Training by Tonex is tailored for professionals involved in the development of Class 3 medical devices, focusing on best practices in systems engineering within an Agile framework.
It addresses the unique challenges of creating high-quality, reliable, and regulatory-compliant medical device software. The course emphasizes practical skills for developing good requirements, architecture (including cloud and IoT), interfaces, and conducting hazard analyses.
It also covers systems design, integration, verification, validation, and the application of Agile methodologies, specifically referencing AAMI TIR-45.
Learning Objectives:
- Develop Effective Systems Engineering Skills: Understand the principles of systems engineering for Class 3 medical devices.
- Create Robust Requirements and Architecture: Learn to develop clear requirements and effective architectures for traditional, cloud, and IoT systems.
- Design Efficient Interfaces: Master the art of creating interfaces with high cohesion and low coupling.
- Conduct Hazard Analysis and FMEA: Gain expertise in performing hazard analysis and Failure Modes Effects Analysis.
- Understand System Design and Integration: Learn the best practices in system design and integration.
- Execute System Verification and Validation: Master the techniques for system verification and validation.
- Apply Agile Practices in Systems Engineering: Explore how to integrate Agile methodologies, with a description on TIR-45, in the systems engineering of medical devices.
Target Audience:
- Systems Engineers and Software Developers in the Medical Device Sector
- Project Managers and Agile Practitioners in Medical Technology
- Quality Assurance and Regulatory Compliance Professionals
- Technical Leads and Architects in Medical Device Companies
Course Outlines:
Introduction to Systems Engineering for Class 3 Medical Devices
- Overview of systems engineering in the medical device context
- Unique challenges and regulatory environment
Developing Effective Requirements
- Techniques for creating clear and robust requirements
- Requirements management in an Agile environment
Architectural Design for Medical Devices
- Designing architectures for traditional, cloud, and IoT-based systems
- Best practices in architectural design
Interface Design
- Principles of high cohesion and low coupling in interface design
- Practical strategies for effective interface development
Hazard Analysis and FMEA in Medical Devices
- Conducting comprehensive hazard analysis
- Implementing Failure Modes Effects Analysis effectively
Systems Design and Integration
- Strategies for effective system design
- Best practices in system integration
System Verification and Validation
- Techniques and methodologies for system verification
- Approaches to system validation
Agile Systems Engineering with TIR-45
- Integrating Agile methodologies in systems engineering
- Applying AAMI TIR-45 in Agile software development
Delivery Format:
- Online Lectures and Interactive Workshops
- Case Studies and Real-world Examples
- Group Projects and Discussions
Assessment:
- Weekly Assignments and Quizzes
- Final Project: Designing a Systems Engineering Plan for a Class 3 Medical Device
This course offers a comprehensive framework for professionals in the medical device industry to enhance their systems engineering practices, especially in the rapidly evolving field of Agile software development.