Design for Reliability in Medical Devices Essentials Training by Tonex
Design for Reliability in Medical Devices Essentials Training by Tonex provides a comprehensive understanding of how to build dependable and safe medical devices that meet regulatory standards and perform consistently throughout their lifecycle. This course introduces proven reliability engineering tools such as Failure Modes and Effects Analysis (FMEA), Highly Accelerated Life Testing (HALT), and Highly Accelerated Stress Screening (HASS), tailored specifically for medical technology. The program also explores how reliability impacts cybersecurity—reliable devices reduce attack surfaces, improve firmware integrity, and enhance system resilience under threat. As cyber risks continue to grow in healthcare, integrating cybersecurity within reliability design is now critical.
Audience:
- Biomedical Engineers
- Medical Device Designers
- Quality Assurance Specialists
- Regulatory Affairs Professionals
- Cybersecurity Professionals
- Product Managers and Compliance Officers
Learning Objectives:
- Understand reliability engineering principles for medical devices
- Apply FMEA to identify and mitigate failure risks
- Explore HALT/HASS techniques to improve design robustness
- Integrate cybersecurity within reliability planning
- Align reliability strategies with FDA and ISO standards
- Improve lifecycle performance and reduce recalls
Course Modules:
Module 1: Foundations of Reliability
- Principles of reliability engineering
- Importance of reliability in healthcare
- Lifecycle reliability considerations
- Role of reliability in patient safety
- Overview of regulatory requirements
- Cybersecurity relevance in design
Module 2: FMEA for Medical Devices
- Introduction to FMEA process
- Identifying failure modes in systems
- Severity, occurrence, detection rankings
- Risk Priority Number (RPN) analysis
- Design and Process FMEA comparison
- Integration with cybersecurity risk
Module 3: HALT/HASS Methodologies
- Purpose of HALT and HASS testing
- Setting up stress screening protocols
- Identifying design weaknesses
- Accelerated aging for device validation
- Implementing corrective design actions
- Cyber failure points during stress
Module 4: Compliance and Standards
- FDA expectations for reliability
- ISO 14971 risk management overview
- IEC 60601 compliance basics
- Documentation best practices
- Audit readiness and evidence trails
- Reliability data in cybersecurity audits
Module 5: Cybersecurity-Driven Reliability
- Device trustworthiness under threat
- Firmware integrity checks
- Secure boot and fail-safe mechanisms
- Threat modeling during design
- Post-market cybersecurity monitoring
- Aligning reliability with cyber policies
Module 6: Practical Reliability Strategies
- Design margin and derating principles
- Redundancy and fault tolerance
- Environmental and usability testing
- Supplier reliability management
- Root cause analysis and CAPA
- Long-term performance tracking
Secure your spot in Design for Reliability in Medical Devices Essentials Training by Tonex and gain the knowledge to build safer, more reliable, and cyber-resilient medical devices. Strengthen your expertise in aligning engineering design with patient safety and cybersecurity standards. Register today and be part of the next wave of innovation in healthcare technology.