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This course discusses how risk management is applied in the medical device  and in vitro diagnostic (IVD) industries. Topics delve into risk management concepts and tools, including hazard identification, hazard analysis, fault tree analysis, failure modes and effects analysis (FMEA), Hazard Analysis and Critical Control Point (HACCP), mitigation application, regulatory requirements, the creation of risk management plans, reports and files, how to conduct Risk Management Reviews, and what might be audited in your Risk Management System.

Course Objectives

By the end of the course, you'll be able to conduct risk management for a variety of products, processes and services within the medical device industry and beyond.

  • Develop an understanding of Risk Management as part of the product and process development cycle by defining a hazard, levels of risk, types of harm, and to rank risk mitigation activity
  • Prepare a Hazard Analysis including hazards, hazardous situations, harms, and understand risk estimation
  • Perform a HACCP (Hazard and Critical Control Points) analysis as a qualitative process hazard analysis for process risk management for any process
  • Perform and assess the application and results that critical tools of quality such as a Failure Modes and Effects Analysis (FMEA) and Fault Tree Analysis (FTA) can provide
  • Compose and document mitigations to risk in a suitable regulatory format
  • Enumerate the fundamental documentation requirements of ISO 14971 (Medical Devices – application of risk management to medical devices)
  • Prepare a Risk Management Plan in a device, a diagnostic product, or a process, which describes the tasks involved in successfully leading an ISO Quality System implementation project from start-up through Registration
  • Apply structured qualitative and quantitative risk management concepts and tools leading to a documented Risk Management Plan and Risk Management File that can be used in any due diligence for reducing risk in product, process or service development

Course curriculum

    1. Before we begin...

    2. How to use this course

    1. What is Risk

    2. Application of Risk to Design Controls

    3. ISO 14971 versions

    1. Terms and Definitions

    2. Application of Risk Management

    3. General Requirements

    1. Risk Management Plan and File Introduction

    2. RMP - Scope, Responsibilities, and Review

    3. RMP - Risk Acceptability, Overall Residual Risk, Verification

    4. RMP - Production and Post-Production Part 1

    5. RMP - Example

    6. RMP - Production and Post-Production Part 2

    1. Terms and Definitions

    2. Intended Use and Reasonably Foreseeable Misuse

    3. Identification of Characteristics Related to Safety

    1. Hazardous Situations

    2. Risk Estimation

    3. Risk Evaluation

    4. Selection of Risk Assessment Techniques

About this course

  • $595.00
  • 44 lessons
  • 15.5 hours of video content
  • 90-day access to course

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Risk Management for Medical Devices