Length: 2 Days
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FMEA, FTA and Risk Assessment for Medical Devices | Training Bootcamp

FMEA, FTA and Risk Assessment for Medical Devices

FMEA, FTA and Risk Assessment for Medical Devices is a 2-day training bootcamp that details a unique and powerful approach to integrating medical device risk assessment, Process FMEA (PFMEA), Design FMEA (DFMEA), Failure Mode and Effects and Criticality Analysis (FMECA) and Fault Tree Analysis (FTA). Participants are introduced to a set of tools and methods to identify medical device risk assessment.

FMEA, FTA and Risk Assessment for Medical Devices training course helps you to use risk assessment methods, Failure Mode and Effects (FMEA) and Fault Tree Analysis (FTA) Analysis, widespread methods in root cause failure analysis, reliability, safety, risk assessment and quality management. Learn how FMEA and FTA are used by medical device manufacturers to prevent medical devices and product errors and failures and thus, increase product safety.

FMEA for Medical Devices covers 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, Process FMEA (PFMEA), Design FMEA (DFMEA), Fault Tree Analysis (FTA), case studies and examples, quizzes, medical device FMEA excel template (editable), and North American, European, and Asian regulatory references.

The process FMEA (PFMEA) is a method for the systematic analysis of risks resulting from failure modes in processes. Medical device manufacturers require to identify and control process risks and align with MDR and ISO 13485 standard.

Fault Tree Analysis (FTA) is a top-down risk analysis tool used in medical device design and architecture. Fault tree analysis starts with a failure and works back to the component.  FTA maps the relationship between faults, subsystems, and redundant safety design elements by creating a tree shape diagram, using Boolean logic to analyze overall system.

Essentially, an FTA starts with the “big event”, like an injury done to a patient or operator. It then works backward through several levels or “logic gates” on the tree that lead to reasons why the failure would happen. For example, if the injury happened due to mechanical failure, why was there a mechanical failure?

 

ISO-14971

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.

Participants are introduced to a set of tools and methods to identify medical device risk assessment. FMEA, FTA and Risk Assessment for Medical Devices training course helps you to use risk assessment methods, Failure Mode and Effects (FMEA) and Fault Tree Analysis (FTA) Analysis, widespread methods in root cause failure analysis, reliability, safety, risk assessment and quality management. Learn how FMEA and FTA are used by medical device manufacturers to prevent medical devices and product errors and failures and thus, increase product safety.

FMEA for Medical Devices covers 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, Process FMEA (PFMEA), Design FMEA (DFMEA), Fault Tree Analysis (FTA), case studies and examples, quizzes, medical device FMEA excel template (editable), and North American, European, and Asian regulatory references.

HOW YOU WILL BENEFIT

  • Learn key concepts and considerations for a medical device Risk Assessment
  • Apply FMEA , FTA, FMECA,  and other risk management processes/tools to medical devices.
  • Apply different types of FMEA including System FMEA, Design FMEA, Software FMEA and Process FMEA.
  • Apply DFMEAs to evaluate and address potential failure modes either early on in the product design process or in its end stages
  • Apply PFMEAs to analyze a specific process and ways the process can prevent a defective product from going to market
  • Apply Process Control Plan (PCP) to detect a defective product before it ships.
  • Learn how Process Control Plan (PCP), PFMEA and Process Flow Diagram (PFD) to show that the highest-risk failures has been dramatically decreased.
  • Gain support for Failure Mode and Effects and Criticality Analysis (FMECA) and corrective and preventive action.
  • Learn how Fault Tree Analysis (FTA) method is used for uncovering future events that may lead to a major fault or failure.
  • Use FTA to increase visibility into events most likely to lead to failures.
  • Integrate FMEA with FMECA and FTA for Medical Device Risk Assessment, Safety and Reliability analysis
  • Make decisions based on failure modes and their severity.

Learning Objectives

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 and Failure Mode and Effects and Criticality Analysis (FMECA).
  • Complete a sample medical device Process FMEA.
  • Complete a sample medical device FMECA.
  • Complete a sample medical device FTA.

Course Outline

Overview of Medical Device Risk Assessment

  • Design and development of Class II and III medical devices
  • Basic principles of Risk Management for medical devices
  • Risk management tools in the medical device industry
  • Key considerations for a medical device risk assessment
  • Medical device hazard evaluations
  • Overview of ISO 14971 standard for producing and maintaining a risk management
  • Risks in the context of ISO 14971Safety of a medical device and correct and incorrect use of that device.
  • Applying IEC-62304 and FDA guidance based software life cycle processes

Medical device Risk Management 

  • Medical device Risk Management Plan
    Medical device Risk Analysis
  • Medical device Risk Evaluation
  • Medical device Risk Controls
  • Medical device Risk Management Review
  • Medical device Production & Post-Production Information
  • Identify, analyze, and mitigate risk in the design and development process
  • Risk management tools in the medical device industry
  • Preliminary Hazards Analysis (PHA)
  • Failure Modes and Effects Analysis (FMEA)
  • Fault Tree Analysis (FTA)
  • Fishbone or Ishikawa diagramming and brainstorming

Basic Failure Mode and Effects Analysis (FMEA) Approach

  • Different types of FMEA for medical devices: Design and Process FMEA
  • How FMEA works
  • Advantages of FMEA
  • Limitations of FMEA
  • Applications for FMEA
  • Design vs. Process 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
  • FTA as a top-down approach that analyzes an event or failure mode
  • FTA to reach the true cause of the failure, and identify risk control measures
  • FTA IEC 61025 standard
  • Fault tree description and structure, objectives, applications, and combinations with other reliability analysis techniques
  • FTA-FMEA
  • FTA-ETA
  • Development and evaluation
  • Fault tree development and evaluation
  • System familiarization, fault tree developments, fault tree construction, and failure rates in FTA.
  • FTA symbols and detailed procedure.

Applications for FTA in Medical Devices

  • Fault Tree Analysis (FTA) applied to system, process, or product failures
  • FTA to predict failure events and potential causes.
  • FTA to analyze a complex system containing numerous interconnected causes of failure.
  • Performing FTA to identify causes of a failure after it has happened.
  • Using FTA to identify causes of a potential system failure during the design process.
  • Advantages of FTA
  • Limitations of FTA
  • What are the differences between FMEA and FTA?
  • Fault Tree Analysis (FTA) vs. Event Tree Analysis (ETA)
  • Design reviews of medical devices with FTA
  • Using FTA by pacemaker manufacturers based on FDA guidance for software aspects of 510(k) notification submissions for medical devices
  • Computer-controlled medical devices using FTA as a primary risk analysis tool

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.

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