Product Systems Engineering Workshop – MedTech Edition Essentials Training by Tonex
The Product Systems Engineering Workshop – MedTech Edition Essentials Training by Tonex provides a comprehensive framework for applying systems engineering in medical device and healthcare technology environments. This workshop focuses on aligning engineering practices with ISO 13485, IEC 62304, ISO 14971, and FDA CFR Part 820 standards, ensuring risk-based design, traceability, and usability.
Participants will learn how to bridge clinical requirements to robust software and hardware solutions while ensuring compliance. Additionally, the course covers cybersecurity’s critical role in safeguarding medical systems against threats, reinforcing secure development practices, and protecting sensitive patient data and device integrity.
Audience
- Medtech systems and quality engineers
- Regulatory and clinical development staff
- R&D leads and device project managers
- Embedded software and firmware teams
- Cybersecurity professionals
Learning Objectives
- Implement systems engineering in regulated medical environments
- Model risk controls and safety interlocks from user needs
- Integrate systems and software lifecycle processes
- Align SE workflows with DHF and regulatory submissions
- Use model-based techniques for diagnostics, firmware, and UX
Course Modules
Module 1: Regulatory Frameworks
- Understanding ISO 13485 requirements
- IEC 62304 software lifecycle essentials
- FDA CFR Part 820 compliance overview
- ISO 14971 risk management principles
- Traceability to regulatory submissions
- Managing regulatory change impacts
Module 2: Risk-Based Design
- Identifying and prioritizing risks
- Designing effective safety interlocks
- FMEA and fault tree application
- Mitigating risks in firmware and hardware
- Documenting risk controls
- Auditing risk management processes
Module 3: Human Factors Engineering
- Integrating usability engineering
- Addressing human error in design
- Conducting formative usability tests
- Validating user interface effectiveness
- Designing for accessibility and inclusivity
- Linking human factors to patient safety
Module 4: Systems Integration
- Mapping clinical to technical requirements
- Coordinating hardware-software interactions
- Managing interfaces and interoperability
- Ensuring reliability and maintainability
- Verification and validation strategies
- End-to-end traceability practices
Module 5: Model-Based Systems Engineering
- Introduction to MBSE in medtech
- Using SysML for requirement models
- Simulating diagnostic workflows
- Modeling firmware architecture
- UX modeling for medical devices
- Enhancing documentation with models
Module 6: Cybersecurity in Medical Devices
- Identifying cybersecurity risks in medtech
- Designing secure firmware and interfaces
- Regulatory guidance on cybersecurity (FDA, IEC 81001)
- Managing software updates securely
- Threat modeling for medical devices
- Protecting patient data and device integrity
Take the next step toward mastering systems engineering for medical devices. Enroll in the Product Systems Engineering Workshop – MedTech Edition Essentials Training by Tonex today to elevate your expertise, meet regulatory demands, and contribute to safer, more secure healthcare technologies!