Software Reliability for Medical Devices Training by Tonex
The Software Reliability for Medical Devices course is designed to equip professionals in the healthcare industry with the knowledge and skills necessary to ensure the reliability and safety of software and firmware in FDA-regulated medical devices and equipment. Participants will learn to conduct software and firmware design failure modes effects analysis, root cause analysis, fault tree analysis, and assess reliability using industry-accepted models. The course also provides guidance on complying with key standards and regulations such as IEC 62304, ISO 14971, CFR 820, and EU MDR.
Learning Objectives:
By the end of this course, participants will:
- Learn the importance of software reliability in FDA-regulated medical devices and equipment.
- Be proficient in conducting and facilitating software and firmware design failure modes effects analysis (FMEA) for medical devices.
- Learn how to perform root cause analysis for software and firmware defects to focus development and testing efforts effectively.
- Assess software and firmware reliability using industry-accepted models.
- Identify feasible alternatives for improving software reliability in medical devices.
- Review and optimize software and firmware development processes for reliability.
- Conduct and facilitate software and firmware fault tree analysis to drive requirements and design improvements.
- Provide recommendations for enhancing processes and software while ensuring on-time delivery.
- Estimate software and firmware reliability growth using recognized models.
- Gain expert guidance on compliance with IEC 62304, ISO 14971, CFR 820, and EU MDR.
Audience:
This course is ideal for professionals involved in the development, testing, quality assurance, regulatory affairs, and compliance of software and firmware in medical devices and equipment. The target audience includes:
- Medical Device Engineers
- Quality Assurance Specialists
- Regulatory Affairs Professionals
- Product Development Managers
- Software Developers
- Test Engineers
- Anyone responsible for ensuring software reliability in medical devices
Course Outline:
Introduction to Software Reliability in Medical Devices
- Overview of the significance of software reliability.
- Regulatory requirements and standards (FDA, IEC 62304, ISO 14971, CFR 820, EU MDR).
- Safety implications and patient impact.
Software and Firmware Design FMEA
- Principles of design failure modes effects analysis (FMEA).
- Conducting FMEA for software and firmware in medical devices.
- Prioritizing failure modes for effective mitigation.
Root Cause Analysis for Defects
- Methods and techniques for root cause analysis.
- Tailoring development, review, and testing efforts based on prevalent defects.
- Real-world case studies and exercises.
Software and Firmware Reliability Assessment
- Industry-accepted models for reliability assessment (e.g., MTBF, MTTF, reliability growth models).
- Analyzing software reliability data.
- Interpreting reliability metrics.
Improving Software Reliability
- Identifying feasible alternatives for improving software reliability.
- Implementing best practices and strategies.
- Cost-benefit analysis for reliability enhancements.
Process Optimization for Reliability
- Reviewing and optimizing software and firmware development processes.
- Ensuring process alignment with reliability goals.
- Continuous improvement strategies.
Software and Firmware Fault Tree Analysis
- Principles of fault tree analysis for software and firmware.
- Top-down approach for driving requirements and design improvements.
- Practical exercises and case studies.
Process Improvement and On-Time Delivery
- Providing recommendations for enhancing processes and software.
- Balancing process improvements with on-time delivery.
- Managing project timelines effectively.
Estimating Reliability Growth
- Estimating software and firmware reliability growth using recognized models.
- Predicting reliability improvements over time.
- Monitoring and adjusting reliability goals.
Regulatory Compliance and Standards
- Expert guidance on compliance with IEC 62304, ISO 14971, CFR 820, and EU MDR.
- Best practices for navigating regulatory requirements.
- Case studies illustrating successful compliance strategies.
This course equips professionals with the knowledge and expertise needed to ensure the reliability and compliance of software and firmware in FDA-regulated medical devices and equipment, contributing to the safety and effectiveness of healthcare technology.