Certified Medical Safety Software Engineer (CMSE) Certification Program by Tonex
This program provides essential knowledge and skills for medical device software engineers, compliance professionals, and regulatory experts. Participants learn about key safety standards, risk management, validation processes, and cybersecurity for medical software. The course covers IEC 62304, ISO 14971, FDA guidelines, usability engineering, and software verification techniques. It prepares professionals to develop safe, compliant, and reliable medical software. Through expert instruction, case studies, and practical insights, participants gain a comprehensive understanding of medical safety software engineering.
Audience:
- Medical device software developers
- Compliance engineers
- Regulatory professionals
Learning Objectives:
- Understand IEC 62304 and ISO 14971 compliance
- Implement FDA software validation requirements
- Apply risk management techniques for medical devices
- Enhance software safety through usability engineering
- Conduct verification and validation of medical software
Course Modules:
Module 1: Medical Safety Standards for Software
- Overview of IEC 62304 requirements
- Risk management principles in ISO 14971
- FDA software validation guidance
- Compliance with international medical software regulations
- Safety classifications and software documentation
- Case studies on regulatory compliance
Module 2: Embedded and Real-Time Software in Medical Systems
- Real-time operating system (RTOS) safety challenges
- Cybersecurity risks in embedded medical software
- Software integrity and secure coding practices
- Failure prevention in real-time applications
- System design considerations for embedded software
- Case studies on embedded medical software failures
Module 3: Usability Engineering and Human Factors (IEC 62366)
- User-centered design for medical safety
- Human factors engineering principles
- Alarm design and risk mitigation strategies
- Conducting usability testing for medical software
- Regulatory requirements for usability engineering
- Case studies on human factors in medical devices
Module 4: Medical Device Risk Management
- Hazard analysis and risk assessment methods
- Risk controls and mitigation strategies
- Failure mode and effects analysis (FMEA)
- Pre-market submissions and approval strategies
- Risk-based approach to software lifecycle management
- Case studies on risk management implementation
Module 5: Testing and Validation for Medical Software
- Static and dynamic analysis techniques
- Verification processes for medical device software
- Automated testing tools and methodologies
- Software validation best practices
- Compliance with regulatory testing requirements
- Case studies on software validation failures
Module 6: Certification and Regulatory Compliance
- Overview of medical software certification processes
- FDA, EU MDR, and other global regulations
- Post-market surveillance and software updates
- Documentation and audit requirements
- Legal and ethical considerations in medical software
- Case studies on regulatory compliance challenges
Exam Domains:
- Medical Software Regulatory Compliance
- Risk Management and Safety Standards
- Embedded and Real-Time Software Safety
- Usability and Human Factors in Medical Software
- Medical Software Testing and Validation
- Medical Software Security and Integrity
Course Delivery:
The course is delivered through lectures, interactive discussions, and expert-led case studies. Participants access online resources, including regulatory documents and industry best practices. Practical exercises enhance understanding of compliance, risk management, and software validation.
Assessment and Certification:
Participants are evaluated through quizzes, assignments, and a final assessment. Those who successfully complete the course receive the Certified Medical Safety Software Engineer (CMSE) certification.
Question Types:
- Multiple Choice Questions (MCQs)
- True/False Statements
- Scenario-based Questions
- Fill in the Blank Questions
- Matching Questions (terms with definitions)
- Short Answer Questions
Passing Criteria:
Candidates must achieve a score of 70% or higher to pass the CMSE Certification Training exam.
Enhance your expertise in medical safety software engineering. Enroll today in the CMSE Certification Program by Tonex and advance your career in medical device compliance and software safety!