FMEA For Medical Devices

FMEA For Medical Devices

FMEA for Medical Devices course helps you to use Failure Mode and Effects Analysis, a widespread method in root cause failure analysis and quality management. Learn how FMEA is used by medical device manufacturers to prevent medical devices and product errors and thus, increase product reliability and safety.

FMEA for Medical Devices course presents a step-by-step method for conducting Failure Mode and Effects Analysis (FMEA) for medical devices. Participants will learn about methodologies, and implementation of medical device FMEA as an essential component of a risk assessment and preventive action program.

FMEA objectives for medical devices will include design and process FMEA, analyzing failure cause and effect, assessment of risks, and preventive action plans for your simple and complex medical devices This course includes theory, practice exercises, job aids, Design FMEA (DFMEA), case studies and examples, quizzes, medical device FMEA excel template (editable), and North American, European and Asian regulatory references.

WHO SHOULD ATTEND

This course is designed for software and hardware engineers, quality assurance, testers, managers, and employees with little or no FMEA experience. The course is also useful for those who have experience with FMEA but have never had any formal training.

HOW YOU WILL BENEFIT

• Learn key concepts and considerations for a medical device Risk Assessment
• Apply different types of FMEA including System FMEA, Design FMEA, Software FMEA and Process FMEA.
• Gain support for Failure Mode and Effects and Criticality Analysis (FMECA) and corrective and preventive action.
• Integrate FMEA with FMECA and FTA for Medical Device Risk Assessment, Safety and Reliability analysis Apply FMEA and risk management process to medical devices.
• Make decisions based on failure modes and their severity.

Participants will learn how to use FMEA process applied to medical devices:

• Describe the purpose of the medical device FMEA process.
• Define the elements of medical device FMEA.
• Assess risk of failure
• Identify the potential failures and the associated relative risks designed into a product or process.
• Analyze and define different medical device failure mode, failure effect, failure cause, severity, occurrence, and detection.
• Complete a sample medical device Design FMEA.
• Complete a sample medical device Process FMEA.
• Complete a sample medical device FMECA.
• Complete a sample medical device FTA.

COURSE MODULES

Overview of Medical Device Risk Assessment

• Basic Principles of Risk Management for medical device design
• Key Considerations for a medical device risk assessment
• Medical device hazard evaluations
• Overview of ISO 14971 standard for producing and maintaining a risk management
• identify, analyze, and mitigate risk in the design and development process

Overview of Failure Mode and Effects Analysis (FMEA)

• Basic Failure Mode and Effects Analysis (FMEA) approach
• Different types of FMEA for medical devices: Design and Process FMEA
• How FMEA works
• Applications for FMEA for medical devices
• Advantages of design and process FMEA
• Limitations of FMEA

Application of FMEA for Medical Devices

• FMEA a subjective analysis
• How to eliminate problems and defects in medical devices
• Root Cause Analysis
• Applying Design and Process FMEA for medical devices
• Examine known causes and unknown effects.
• A medical device FMEA analysis

Applications of FMEA, FMECA and FTA to Medical Device Reliability, safety and Risk Assessment

• Failure Mode and Effects Analysis (FMEA) vs. Failure Modes, Effects and Criticality Analysis (FMECA)
• What are the differences between FMEA and FMEA?
• Fault-Tree Analysis (FTA)
• How FTA works
• Applications for FTA in Medical Devices
• Advantages of FTA
• Limitations of FTA
• What are the differences between FMEA and FTA?

Case Study: Deductive, top-down approach vs inductive, bottom-up approach in medical devices

• Quantitative vs. Qualitative Risk Assessment for Medical Devices
• Correlation between errors, faults and failures
• Quantitative vs. qualitative analysis
• FTA and Probabilistic Risk Assessment (PRA)
• FTA as a quantitative tool.
• Chains of events in FTA and FMEA
• When to use FTA vs. when to use FMEA

Workshop 1: Medical Device Risk Assessment

• Key Considerations
• Define the levels of risk
• Classifications of identified risks qualified by probability and severity
• Mitigating a risk to reduce possible harm to the lowest reasonably achievable level.
• Qualifying risk components
• Probability of occurrence of harm and severity of harm
• A risk matrix
• Risk charts

Workshop 2: Medical devices — Application of risk management to medical devices

• Improving the safety of medical devices
• Basic Principles of Risk Management for Medical Device Design
• Risk Management Flow Chart
• Risk Control
• Risk control and monitoring activities
• Inherent safety by design
• Protective measures in the device or its manufacture
• Information for safety, such as warnings, maintenance schedules, etc.
• Risk Control Measures
• Protective measures, e.g. default operating modes
• Risk Assessment Matrix

Coursework

Engaging learning experiences with interactive content such as practice labs, interactive activities, videos, and assessments along the way. Bring it all together and test what you learned with a final exam.

PROOF OF COMPLETION

Verification may come as a certificate of completion, statement of attendance, or a digital learning badge depending on the course.