Fundamentals of Medical Device Engineering for Industrial and Production Engineers & Technicians Training by Tonex
This comprehensive course, designed and delivered by Tonex, delves into the intricate world of Medical Device Engineering, equipping industrial and production engineers and technicians with the essential knowledge and skills to excel in the specialized domain of medical technology. Covering critical concepts and regulatory considerations, this training will empower professionals to contribute effectively to the design, development, and manufacturing of medical devices, ensuring compliance with industry standards.
Learning Objectives: By the end of this course, participants will be able to:
- Learn the fundamentals of medical device engineering and its significance in healthcare.
- Navigate the complex landscape of medical device regulations and quality assurance.
- Demonstrate proficiency in product development processes for medical devices.
- Grasp the principles of risk management and mitigation in medical device engineering.
- Master the art of design control and validation in medical device production.
- Develop the skills necessary to ensure compliance with international standards, including ISO 13485.
Audience: This course is tailored for industrial and production engineers, technicians, and professionals involved in medical device manufacturing. It is suitable for those who aspire to excel in the field of medical technology, compliance, and quality assurance, as well as individuals looking to enhance their understanding of medical device engineering.
Course Outline:
Introduction to Medical Device Engineering
- The Role of Medical Devices in Healthcare
- Regulatory Framework and Compliance
- Medical Device Classification and Risk Assessment
- Industry Trends and Innovations
- Ethical Considerations in Medical Device Engineering
- Case Studies: Successes and Failures
Medical Device Quality Management
- Quality Management Systems (QMS) for Medical Devices
- ISO 13485: Principles and Implementation
- Good Manufacturing Practices (GMP)
- Post-Market Surveillance and Reporting
- Audits and Inspections
- Best Practices in Quality Control
Product Development in Medical Device Engineering
- Product Life Cycle Management (PLM)
- Design and Development Process
- Prototyping and Testing
- Regulatory Approvals and Clinical Trials
- Design for Manufacturability (DFM)
- Project Management in Medical Device Development
Risk Management in Medical Device Engineering
- Risk Analysis and Assessment
- Hazard Analysis and Critical Control Points (HACCP)
- Failure Modes and Effects Analysis (FMEA)
- Risk Mitigation Strategies
- Human Factors Engineering
- Case Studies on Risk Management
Design Control and Validation
- Design Control Processes
- Validation and Verification Techniques
- Usability Engineering
- Design Changes and Configuration Management
- Design Review and Documentation
- Case Studies on Successful Device Design
International Standards and Regulatory Compliance
- Overview of Global Regulatory Authorities
- CE Marking and European Medical Device Regulations (MDR)
- FDA Regulations and 510(k) Submissions
- Post-Market Surveillance (PMS)
- Labeling and Packaging Requirements
- Preparing for Regulatory Audits
This course equips participants with the knowledge and skills necessary to thrive in the ever-evolving world of medical device engineering, ensuring the production of safe, effective, and compliant medical devices.