Medical Device Systems Engineering and Management Training by Tonex
The Medical Device Systems Engineering and Management Training Course by Tonex is designed to provide comprehensive knowledge and skills required for the development, deployment, and management of medical device systems. Participants will delve into the intricacies of medical device engineering principles, regulatory compliance, risk management, and project management within the context of the healthcare industry. Through a combination of theoretical presentations, practical case studies, and interactive discussions, participants will gain a thorough understanding of the lifecycle of medical device systems from conceptualization to market release and beyond.
Learning Objectives:
- Understand the fundamentals of medical device systems engineering and its application in healthcare technology.
- Explore regulatory frameworks and standards governing the development and commercialization of medical devices.
- Learn strategies for effectively managing projects related to medical device systems, including scheduling, resource allocation, and risk mitigation.
- Gain insights into the design and integration of medical device systems, considering factors such as usability, safety, and interoperability.
- Develop proficiency in conducting risk assessments and implementing risk management strategies specific to medical device systems.
- Acquire knowledge of quality management systems and their significance in ensuring compliance and product excellence.
- Explore emerging trends and technologies shaping the future of medical device systems engineering and management.
Audience: This course is ideal for professionals involved in the development, deployment, or management of medical device systems, including:
- Biomedical engineers
- Systems engineers
- Product managers
- Regulatory affairs specialists
- Quality assurance professionals
- Project managers
- Healthcare industry professionals seeking to expand their knowledge in medical device systems engineering and management.
Course Outlines:
Module 1: Fundamentals of Medical Device Systems Engineering
- Introduction to Medical Device Systems Engineering
- Overview of Healthcare Technology Landscape
- Design Controls and Documentation Requirements
- Human Factors Engineering in Medical Devices
- System Architecture and Integration
- Verification and Validation Processes
Module 2: Regulatory Compliance and Standards
- FDA Regulations for Medical Devices
- ISO 13485 Quality Management System
- Risk Management According to ISO 14971
- Medical Device Directive (MDD) and Medical Device Regulation (MDR) in EU
- International Regulatory Harmonization
- Post-Market Surveillance and Vigilance
Module 3: Project Management in Medical Device Systems Engineering
- Project Planning and Scheduling
- Resource Management and Allocation
- Risk Assessment and Mitigation Strategies
- Stakeholder Communication and Collaboration
- Change Control and Configuration Management
- Agile Methodologies in Medical Device Development
Module 4: Design and Integration of Medical Device Systems
- Conceptualization and Requirements Gathering
- System Design and Architecture Planning
- Prototyping and Iterative Development
- Usability Engineering and User Experience Design
- Interoperability and Connectivity Considerations
- Regulatory Compliance in Design Control
Module 5: Risk Management in Medical Device Systems
- Understanding Risk Management Process
- Hazard Identification and Risk Assessment Techniques
- Risk Control and Mitigation Strategies
- Risk Management Throughout the Product Lifecycle
- Human Factors and Usability Considerations in Risk Management
- Documentation and Reporting Requirements
Module 6: Emerging Trends and Technologies
- Innovations in Medical Device Systems Engineering
- Wearable and Implantable Medical Devices
- Internet of Medical Things (IoMT) and Connected Health
- Artificial Intelligence and Machine Learning in Healthcare
- Regulatory Challenges and Opportunities with Emerging Technologies
- Ethical and Privacy Considerations in Medical Device Innovation