Mastering Risk Management: An ISO 14971 Course for Medical Device Professionals

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This rigorous course/webinar offers comprehensive instruction on the risk management requirements of ISO 14971:2019, which are now harmonized with the EU Medical Device Regulation (MDR) and US FDA opinions on risk governing medical device development. Participants will gain the practical skills and critical knowledge needed to successfully analyze, evaluate, and control medical device ensuring compliance and quality across the device's full lifecycle. This includes post-market risk surveillance and benefit-risk analysis of residual risks, with consideration to the State of the Art.

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This training takes place in one of two formats (your choice): 

• Three-day in-person training (8 hours/day) located at your site

• Five-day remote online training (4 hours/day)

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Medical Device Risk Management Course Objectives:

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After taking this course, you will be able to:

• Define the parts of the risk management process:

  • Risk Analysis​

  • Risk Evaluation

  • Risk Control

  • Benefit-Risk Analysis

• Explain the connection of the risk management process to other essential Quality Management System (QMS) processes

• Become familiar with risk documentation within the Medical Device File (MDF)

 

Who should take this course?

• Engineers and device team members new to their jobs

• Team members that require proof of training in medical device Risk Management (certificate awarded at end of course)

• Experienced device professionals looking to brush up on regulations

• Recommended for professionals in QA/RA, R&D, Marketing, Production Management, and any role associated with the device development and maintenance function

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Course Overview

 

Introduction to Risk Management

• Purpose of risk management 

• Define general risk terms

• Requirements from EU, US FDA, MDSAP, and ISO 14971:2019

 

The Risk Management Process

• Risk Planning

• Risk Analysis, Risk Evaluation, and Risk Control

• Purpose and function of the Risk Policy

• Risk management in the QMS and its connections to other processes

 

ISO 14971:2019 Deep Dive

• Structure of ISO 14971:2019 and ISO/TR 24971:2020

• Updated requirements and terms in the 2019 version

• Connection to US FDA and EU

 

Risk Management Planning

• Elements of a risk management procedure

• The risk management plan and its requirements

• Risk acceptability criteria

• Workshop: Construct a Risk Management Plan (RMP)

 

Risk Analysis

• Hazards, hazardous situations, and harms

• Elements of a Risk analysis document

• Characteristics related to safety

• Intended use and reasonably foreseeable misuse

• Workshop: Begin a Risk Analysis

 

Risk Evaluation

• Risk estimation

• Probability and severity of risks

• Risk categories of probability and severity

• Workshop: Continue Risk Analysis

 

Risk Management Tools

• Top-down vs. bottom-up risk tools

• Failure Mode Effects and Analysis (FMEA)

• Fault Tree Analysis (FTA)

• Other risk tools

• Design vs. manufacturing risk analysis

• Workshop: Apply risk tools to Risk Analysis

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Risk Control

• Approaches to risk control

• Implementing risk controls

• Verifying risk controls

• Residual risk evaluation

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Benefit-Risk Analysis (BRA)

• Elements of Benefit

• EU requirements of the BRA

• US requirements of the BRA

• Workshop: Benefit-risk analysis

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Post-market Risk Management

• The Risk Management Report (RMR)

• Risk management reviews

• Post-market risk activities and drivers of risk management

• Data collection in post-market phase

• Workshop: Evaluate an RMR

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