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ISO 14971 Medical Device Development & Risk Management

Robert Ryan

This comprehensive course provides an in-depth education on the application of risk management per

You will learn to avoid the major mistakes people make that stifle new medical device product developments. Access countless practical examples providing you with the knowledge to easily develop safe and effective medical devices in the fastest possible time. Peek behind the curtain at our medical device templates documentation pack designed to make your regulatory submissions a walk in the park.

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This comprehensive course provides an in-depth education on the application of risk management per

You will learn to avoid the major mistakes people make that stifle new medical device product developments. Access countless practical examples providing you with the knowledge to easily develop safe and effective medical devices in the fastest possible time. Peek behind the curtain at our medical device templates documentation pack designed to make your regulatory submissions a walk in the park.

This course is designed for working professionals in the medical device industry, including (electronic, mechanical, system, firmware) engineers, software developers, firmware developers, data scientists, quality assurance specialists, regulatory affairs professionals, project managers, and others involved in medical device development and compliance.

The course is fully aligned with You will learn how to apply each phase of the risk management process outlined in the standard to medical device design and development.

It is recommended to complete the course over 5 days, taking about 4 hours a day to complete, and upon successful completion, participants will be proficient in medical device development & the application of medical device risk management over the entire medical-device lifecycle.

Start your journey today to become a medical device development & risk management expert.

Enroll now

What's inside

Learning objectives

  • By completing this course you will gain a comprehensive knowledge of medical device development and risk management per iso 14971:2019
  • Understand when and how to apply risk management through a the medical device lifecycle.
  • Understand how to plan a medical device development.
  • Gain a deep understanding of medical device design controls and systems engineering principles.
  • Understand how iso 14971 relates to other important international standards including iec 60601, iec 62304 and iso 13485.
  • Have a clear understand how to easily document design control and risk management activities.

Syllabus

Why is Risk Management Important ?
What you will learn ?

Please download and print the notes from the resources section.

What is RISK ?
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Short Exam
Medical Devices and Risk
What is a MEDICAL DEVICE?
Design Traceability
What is RISK MANAGEMENT?
MEDICAL DEVICE Failures
MEDICAL DEVICE BENEFITS
ISO 14971 and the CFR/MDR
Medical Device Development
Chapter 2 Course Notes
The LIFECYCLE
Design & Development Overview
Document Templates
ISO 14971 and ISO 13485
Phase Strategy
Planning
Documentation and RECORD-Keeping
INTENDED USE

The INTENDED USE statement for a MEDICAL DEVICE can include information on

USER NEEDS & VALIDATION

Download and check out the product development plan template below.


Remember: This word document is created by copying and pasting the major sections from the product development project excel to the word, which is typically done at a phase-exit or if significant changes are made to a document.

REQUIREMENTS and Architecture
SYSTEM Architecture

Some people end up calling this document the user needs specification, I prefer the naming user needs document, it is used to capture the INTENDED use and USER NEEDS statements for the device.

Download this file, and check it out for yourself.


Phase Strategy for a Complex Product
Design PROCESS and DESIGN OUTPUTS
Product Requirements Document Template
VERIFICATION
Is our Digital Thermometer Safe?
Product Detailed Design Specification Template

This document basically provides a list of tests that will be conducted as part of the products design verification testing.

Be sure to download it, have a look through it, and understand it's purpose.

Again this document like the others was created by defining the test cases in the "PRJ-0 Product Development Project" excel document and simply copying and pasting the actual test cases to the word document itself.

This document is very similar to the test protocol, except it acts as a record of actually performing the tests, hence it must record

-> who conducted the testing

-> what exact devices were tested

-> what exact test equipment was used to conduct the testing and proof this equipment was calibrated

This document does not go under version control like the others, as once a test result is recorded it cannot change. However it is still independently reviewed for completeness.

Design Review Template
Common Questions
Risk Management per ISO 14971
Download Chapter 3 Notes
RISK ASSESSMENT
Verify RISK CONTROL
RISK ANALYSIS
REASONABLY FORESEEABLE MISUSE
Characteristics Related to Safety
HAZARDS
Risk Estimation
Quantitative Probability Estimation
Qualitative Probability Estimation
SEVERITY of HARM
Advice from the Trenches
Evaluating RISK
RISK CONTROL
RESIDUAL RISK
RISKS arising from RISK CONTROL measures
Completing RISK MANAGEMENT
Documentation Templates
Risk Management Procedure (Free Preview)
A List of Common HAZARDS
Other International Standards
FMEA and ISO14971 (Part 1)
FMEA and ISO14971 (Part 2)
Production and Post-Production
Download Chapter 4 Notes
LIFECYCLE (Recap)
Implementing Reviews and Actions
RISK CONTROLS in Production & Post-Production
PFMEA
Information
Information Review
Actions
Data Collection
BUG-Tracking Procedure
Change Control Procedure
RISK MANAGEMENT In POST-PRODUCTION Example

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Activities

Be better prepared before your course. Deepen your understanding during and after it. Supplement your coursework and achieve mastery of the topics covered in ISO 14971 Medical Device Development & Risk Management with these activities:
Review Medical Device Regulations
Strengthen your understanding of the regulatory landscape surrounding medical devices. This will provide a solid foundation for understanding the importance of risk management within the medical device lifecycle.
Show steps
  • Identify key regulatory bodies (FDA, EU).
  • Review basic requirements for medical device approval.
  • Summarize the key differences between FDA and EU regulations.
Review 'ISO 14971:2019: A Practical Guide'
Deepen your understanding of the ISO 14971 standard. This book provides practical guidance and examples to help you apply the standard effectively.
View Putting Knowledge to Work on Amazon
Show steps
  • Read the sections relevant to your project.
  • Compare the book's guidance to the course materials.
  • Identify any areas where you need further clarification.
Read 'Medical Device Design: Innovation from Concept to Market'
Gain a broader perspective on medical device design and development. This book provides practical insights and real-world examples that enhance the course material.
View Putting Knowledge to Work on Amazon
Show steps
  • Read the chapters related to risk management and design controls.
  • Take notes on key concepts and examples.
  • Relate the book's content to the course syllabus.
Four other activities
Expand to see all activities and additional details
Show all seven activities
Participate in a Risk Assessment Peer Review
Engage with peers to review and critique risk assessments. This collaborative activity will expose you to different perspectives and improve your ability to identify potential hazards.
Show steps
  • Form a small group with other students.
  • Share your preliminary risk management plans.
  • Provide constructive feedback on each other's plans.
  • Discuss any disagreements or areas of uncertainty.
Create a Risk Management Checklist
Synthesize the key steps and considerations for risk management into a concise checklist. This will serve as a practical tool for future reference.
Show steps
  • Review the ISO 14971 standard and course materials.
  • Identify the essential elements of risk management.
  • Organize the elements into a step-by-step checklist.
  • Refine the checklist for clarity and completeness.
Develop a Preliminary Risk Management Plan
Apply the principles learned in the course to a hypothetical medical device. This hands-on project will solidify your understanding of risk management planning and documentation.
Show steps
  • Choose a medical device (real or hypothetical).
  • Define the intended use and user needs.
  • Identify potential hazards associated with the device.
  • Outline a plan for risk assessment and control.
Develop a Hazard Analysis Template
Create a reusable template for conducting hazard analyses. This deliverable will demonstrate your understanding of the key elements of a hazard analysis and provide a practical tool for future projects.
Show steps
  • Research different hazard analysis methodologies (e.g., FMEA, hazard log).
  • Design a template that captures essential information (hazard, cause, effect, severity, probability, risk control measures).
  • Test the template with a sample medical device.
  • Refine the template based on your testing and feedback.

Career center

Learners who complete ISO 14971 Medical Device Development & Risk Management will develop knowledge and skills that may be useful to these careers:
Risk Manager
A Risk Manager in the medical device industry is responsible for identifying, assessing, and mitigating risks associated with medical devices throughout their lifecycle. This course offers a comprehensive education on risk management per ISO 14971. This means a Risk Manager gains knowledge of the risk management process phases and how to apply them during device design and development. The course may also help someone in this role to understand techniques for documenting risk management activities, which is essential for compliance and traceability. A Risk Manager will appreciate the course’s alignment with industry standards.
See salaries and explore the career path for Risk Manager
Regulatory Affairs Specialist
A Regulatory Affairs Specialist ensures that medical devices comply with all applicable regulations and standards. This course provides an in-depth understanding of medical device risk management per ISO 14971. Such knowledge is essential for preparing regulatory submissions and interacting with regulatory agencies. A Regulatory Affairs Specialist benefits from the course's focus on documenting design control and risk management activities, as this is a significant part of the regulatory submission process. Learning how ISO 14971 relates to standards like IEC 60601, IEC 62304, and ISO 13485 is also highly relevant to the work this professional does.
See salaries and explore the career path for Regulatory Affairs Specialist
Compliance Officer
A Compliance Officer ensures an organization adheres to regulatory guidelines and internal policies related to medical devices. This course provides detailed education on medical device development and risk management per ISO 14971. The compliance officer will benefit from a deep understanding of how ISO 14971 relates to other international standards including IEC 60601, IEC 62304 and ISO 13485. A Compliance Officer may also be involved in documenting design control and risk management activities.
See salaries and explore the career path for Compliance Officer
Quality Assurance Manager
A Quality Assurance Manager ensures that medical devices meet the required quality standards and regulatory requirements. This course provides a comprehensive understanding of medical device development and risk management per ISO 14971, which is directly applicable to the responsibilities of a Quality Assurance Manager. Learning how to apply risk management throughout the medical device lifecycle, as taught within this course, helps ensure product safety and efficacy. Moreover, understanding design controls and systems engineering principles as taught by this course, are critical for maintaining quality throughout the entire development process. A Quality Assurance Manager may also be involved in documenting design control and risk management activities.
See salaries and explore the career path for Quality Assurance Manager
Design Assurance Engineer
The Design Assurance Engineer focuses on ensuring designs meet regulatory requirements and internal quality standards. This course provides key insights into medical device development and risk management via ISO 14971. The Design Assurance Engineer will learn the importance of risk management throughout the lifecycle. Moreover, understanding design controls and systems engineering principles, as taught by this course, are critical for maintaining quality throughout the entire development process. A Design Assurance Engineer may also be involved in documenting design control and risk management activities.
See salaries and explore the career path for Design Assurance Engineer
Medical Device Auditor
The Medical Device Auditor evaluates medical device companies' adherence to regulations and standards. This course provides a comprehensive understanding of medical device development and risk management via ISO 14971, which is directly applicable to the responsibilities of a Medical Device Auditor. Learning how to recognize risk management throughout the medical device lifecycle, as taught within this course, helps to better perform audits. Moreover, understanding design controls and systems engineering principles, as taught by this course, are critical for maintaining quality throughout the entire development process. A Medical Device Auditor may also be involved in documenting design control and risk management activities.
See salaries and explore the career path for Medical Device Auditor
Medical Device Engineer
The Medical Device Engineer designs and develops medical devices, ensuring they are safe, effective, and compliant with regulations. This course provides a comprehensive understanding of medical device development and risk management per ISO 14971, which is directly applicable to the responsibilities of a Medical Device Engineer. Learning how to apply risk management throughout the medical device lifecycle, as taught within this course, helps ensure product safety and efficacy. Moreover, understanding design controls and systems engineering principles, as taught by this course, are critical for maintaining quality throughout the entire development process. A Medical Device Engineer will also be involved in documenting design control and risk management activities.
See salaries and explore the career path for Medical Device Engineer
Project Manager
A Project Manager oversees medical device development projects, ensuring they are completed on time, within budget, and in compliance with regulations. This course provides an in-depth education on medical device development and the application of risk management per ISO 14971. This knowledge is directly applicable to a Project Manager, who must understand how to plan a medical device development and apply risk management throughout the device lifecycle. The course also helps in understanding design controls and systems engineering principles, which are critical for project success. A Project Manager may also be involved in documenting design control and risk management activities.
See salaries and explore the career path for Project Manager
System Engineer
The System Engineer designs, integrates, and manages complex systems for medical devices. This course provides a comprehensive understanding of medical device development and risk management per ISO 14971, which is directly applicable to the responsibilities of a System Engineer. Learning how to apply risk management throughout the medical device lifecycle, as taught within this course, helps ensure product safety and efficacy. Moreover, understanding design controls and systems engineering principles, as taught by this course, are critical for maintaining quality throughout the entire development process. A System Engineer will also be involved in documenting design control and risk management activities.
See salaries and explore the career path for System Engineer
Test Engineer
A Test Engineer designs and executes tests to ensure medical devices function correctly and meet safety standards. This course provides insights into medical device development and risk management per ISO 14971. The Test Engineer will learn the importance of risk management throughout the lifecycle. Moreover, understanding design controls and systems engineering principles, as taught by this course, are critical for maintaining quality throughout the entire development process. A Test Engineer may also be involved in documenting design control and risk management activities.
See salaries and explore the career path for Test Engineer
Product Manager
The Product Manager guides the development and launch of medical devices, balancing market needs with regulatory requirements. This course provides a crucial understanding of ISO 14971. A Product Manager benefits from understanding risk management principles and how they integrate into the device lifecycle. The course’s focus on planning a medical device development may be relevant to the work this professional does. A Product Manager may also ensure that design control and risk management activities are properly documented.
See salaries and explore the career path for Product Manager
Firmware Engineer
The Firmware Engineer develops and tests firmware for medical devices, focusing on reliability and compliance. This course provides a comprehensive understanding of medical device development and risk management per ISO 14971, which is directly applicable to the responsibilities of a Firmware Engineer. Learning how to apply risk management throughout the medical device lifecycle, as taught within this course, helps ensure product safety and efficacy. Moreover, understanding design controls and systems engineering principles, as taught by this course, are critical for maintaining quality throughout the entire development process. A Firmware Engineer will also be involved in documenting design control and risk management activities.
See salaries and explore the career path for Firmware Engineer
Software Developer
The Software Developer creates and maintains software for medical devices, adhering to strict safety and regulatory standards. This course provides a comprehensive understanding of medical device development and risk management per ISO 14971, which is directly applicable to the responsibilities of a Software Developer. Learning how to apply risk management throughout the medical device lifecycle, as taught within this course, helps ensure product safety and efficacy. Moreover, understanding design controls and systems engineering principles, as taught by this course, are critical for maintaining quality throughout the entire development process. A Software Developer will also be involved in documenting design control and risk management activities.
See salaries and explore the career path for Software Developer
Data Scientist
A Data Scientist analyzes data related to medical device performance and safety, using statistical techniques to identify potential risks and improve device design. This course provides a comprehensive understanding of medical device development and risk management per ISO 14971, which is directly applicable to the responsibilities of a Data Scientist. Learning how to apply risk management throughout the medical device lifecycle, as taught within this course, helps ensure product safety and efficacy. Moreover, understanding design controls and systems engineering principles, as taught by this course, are critical for maintaining quality throughout the entire development process. A Data Scientist will also be involved in documenting design control and risk management activities.
See salaries and explore the career path for Data Scientist
Clinical Research Associate
A Clinical Research Associate manages clinical trials for medical devices, ensuring data integrity and patient safety. This course provides an in-depth education on the application of risk management per ISO 14971 during medical device development and can be useful for Clinical Research Associates, especially regarding patient safety considerations. Understanding how ISO 14971 relates to other international standards is also valuable. While a Clinical Research Associate typically requires an advanced degree, this course may provide a deeper understanding of risk management practices.
See salaries and explore the career path for Clinical Research Associate

Reading list

We've selected one books that we think will supplement your learning. Use these to develop background knowledge, enrich your coursework, and gain a deeper understanding of the topics covered in ISO 14971 Medical Device Development & Risk Management.
Cover image
Putting Knowledge to Work
Save
Provides a comprehensive overview of the entire medical device design process, from initial concept to market launch. It covers essential topics such as regulatory requirements, risk management, and usability engineering. It valuable resource for understanding the practical aspects of medical device development and complements the theoretical knowledge gained in the course. This book is especially helpful for those new to the medical device industry.
Putting Knowledge to Work
Paperback
Check
Putting Knowledge to Work
Kindle Edition
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Effort
13.5 total hours
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Instructor
Robert Ryan
Language
English
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