Course Content

ISO 14971:2019 Risk Management – Advanced Course Content

Name: ISO 14971 Advanced Risk Management Course
Brand: deGRANDSON
SKU: Course 036
Price: 1200 GBP
Availability: InStock

Be an internationally-certified Medical Device Risk Management Professional

deGRANDSON’S Risk Management courses — both foundation and advanced versions — provide you with the Tools, Skills and Knowledge necessary to plan, implement and maintain a Risk Management Programme for your medical device (or component) manufacturing organization.

What will I learn from this ISO 14971 Risk Management – Advanced Course?

This comprehensive Course covering all aspects of medical device risk management is divided into four Modules …

Module 3: Advanced Risk Management including …
- Risk Acceptance
- Risk Control
- Risk Evaluation
- Information for Safety and on Residual Risk
- Role of ISO and IEC Standards in Risk Management
- Risks related to Information Security
- Components and Devices designed without using ISO 14971
- Using ISO 14971 in in-vitro Diagnostic Medical Devices (with examples)
- Online Module 3 Examination
Module 2: Selecting and applying the methods and tools used, including …
- SWIFT – What-If Analysis
- Checklists – various types
- PHA – Preliminary Hazard Analysis
- FTA – Fault Tree Analysis
- ETA – Event Tree Analysis
- FMEA– Failure Mode and Effects Analysis (general)
- dFMEA – Design FMEA
- pFMEA – Process FMEA
- uFMEA – User FMEA
- HAZOP – Hazard and Operability Study
- HACCP – Hazard Analysis & Critical Control Points
- Online Module 2 Examination
Module 0: Introduction and background to the Course
Module 1: Application of Risk Management to Medical Devices based on the auditing standard ISO 14971:2019 and includes …
- Risk Management Process
- Management Responsibilities
- Qualification of Personnel
- Risk Management Plan
- Risk Management File
- Risk Analysis process
- Intended use and reasonably foreseeable misuse
- Identification of characteristics related to safety
- Identification of hazards and hazardous situations
- Risk Estimation
- Implementation of risk controls
- Residual risk evaluation
- Benefit-risk analysis
- Completeness of risk control
- Online Module 1 Examination

Course Materials

What materials are included in this ISO 14971 Risk Management – Advanced Course?

These include examples. illustrative figures and a set of Hazard Analysis Templates, namely:

Risk Management Process
Terms and Definitions for ISO 14971
Example Design FMEA
Example Process FMEA
Example User FMEA
Example FMECA Rating Table
Note: Choice of Tools used for Riak Assessment
Note: HACCP Principles and Hazard Analysis
Note: Supply Chain Integrity Best Practice
Fig 1: Hazards – Sequence of Events – Hazardous Situations
Fig 2: Example of Risk Chart
Fig 3: Example of Qualitative 3 x 3 Risk Matrix
Fig 4: Example of Semi-quantitative 5 x 5 Risk Matrix
Fig 5: Sequence of events and risk – Safety
Fig 6: Sequence of events and risk – Information Security
Fig 7: Production and Post-production Information Sources
Fig 8: Example of the application of the P1 x P2 Approach
Form 724-001 SWIFT What-If Analysis
Form 724-002 Hazard Identification Checklist
Form 724-003 Preliminary Hazard Analysis
Form 724-004-A Event Tree Analysis
Form 724-004-B Event Tree Analysis with probabilities
Form 724-005-A FMEA Team Start
Form 724-005-B Design FMEA Scope Worksheet
Form 724-005-C Process FMEA Scope Worksheet
Form 724-005-D FMEA Worksheet (Word file)
Form 724-005-E FMEA Worksheet (Excel file)
Example HACCP Plan

Target Audience

Who should enroll in this ISO 14971 Risk Management – Advanced Course?

This course is intended for:

Senior quality managers
Quality professionals
Regulatory professionals
Compliance professionals
Project managers
Design engineers
Software engineers
Process owners
Quality engineers
Quality auditors
Medical affairs
Legal Professionals

Enrollment

Key Features:

Course is accredited to ISO 21001, the standard for Educational Organizations Management Systems
An ISO 14971 Risk Management certification is awarded upon passing the certification exam
Certificate is immediately available online after the successful passing of the exam
Certificate comes with a shareable QR code for instant verification of credentials
Lessons range from 15 minutes to 1 hour, typically 20–30 minutes, ensuring that each topic is covered in suitable detail
Course includes practice with scenarios that include dialogues
Course includes 24/7 Live-chat Learner Support
Course includes a learner manual, a copy of the standard, and samples of relevant forms and other documents
Course comes with full-audio narration and Closed Captions for accessibility
Courses are hosted on your browser so that no software has to be downloaded avoiding security risks.
Course comes with quizzes, practice with scenarios, and open-book certification exam
Course is hosted on your browser so that no software has to be downloaded avoiding security risks.
Features cross-device compatibility (courses can be taken on any desktop, tablet, or mobile)
Offers full-resume feature (end a session mid-lesson and continue exactly where you left off, even from a different device)
Features real-time interactive content in a secure web-based environment
Offers a clear learning path (once you’ve completed the internal auditor course, you have the option to progress to the lead auditor, up to the consultant and lead auditor course.
Examination and certificate fee are already included in the course fee
Payable via PayPal or Stripe using any credit or debit cards

Enrollment and Registration Process

To enroll in a deGRANDSON’s ISO auditor course, you would need to go through the following steps:

Select desired course
Complete check out proces
Wait for Payment Confirmation email
Check your email for the enrollment instructions
Complete the sign up process

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Delivery

About the Course Author

Dr John FitzGerald graduated with a 1st class honours degree in chemistry and a PhD in synthetic organic chemistry. He worked for 15 years in the manufacturing industry, then as a trainer and consultant in the UK and Ireland before founding deGRANDSON Global in 2009.

He serves as the company Director and course developer while occasionally working as a Lead Auditor on ISO 9001, ISO 13485, ISO 14001, ISO 27001, ISO 45001, and ISO 55001 audits for an accredited certification body (CAB).

How is this ISO 14971 Risk Management – Advanced Course delivered?

deGRANDSON’s risk management courses are delivered online from our Learning Management System (LMS) at www.degrandsonLMS.com (provided by Inquisiq).

All Modules have a full resume and scaling capabilities. This means, for example, you can…

Start a Module at work on your Work Station running on Windows 10,
Continue the Module on the train home on your iPad running on iOS 11 and,
Complete the Module at home on your Notebook PC running on Windows 8.1

Are there any prequalifications to enroll in this ISO 14971 Risk Management – Advanced Course?

For this advanced course, the minimum of a Secondary School Certificate (such as a High School Diploma, Baccalaureate or similar National Vocational Qualification) combined with 5 years work experience, with at least 2 at managerial/supervisory level, is recommended.

A working knowledge of ISO 13485 and relevant regulations is needed to get the maximum benefit from this Course.

You do not have to provide us with any evidence of your qualifications and experience. However, if you do not meet these requirements, you can expect to struggle with the Program.

Certification

Examination and Certification Process

Finish the ISO 14971 Risk Management Advanced Course
Take the certification exam (the exam is free of charge)
Pass the certification exam (you have two attempts to pass it)
Retake the certification exam if necessary
Receive your certificate in your email within 5 minutes after you’ve successfully completed the certification exam

About your ISO 14971 Risk Management Advanced Certification

After successfully passing the certification exam, you will receive your ISO Auditor certificate providing formal recognition of your achievement.

It comes with features designed to enhance its credibility and make it easier to verify and share your qualification with employers, clients, and your professional network.

These include:

Your full name
The type of certificate that was awarded to you
The issuer of the certificate (deGRANDSON Global)
Your credential ID number
The credential signatory (Dr John FitzGerald, Founder and CEO, deGRANDSON Global)
The date the credential was issued
A QR code that links to a page where you can share your credential on your social media profiles

Sample Learner Certificate

ISO 14971 Risk Management Training and Certification Advanced Level Certificate

About deGRANDSON’s Certification

deGRANDSON’s ISO auditor, implementer, and consultant courses are certified to internationally recognized standards, including ISO 21001:2018 for educational organization management, ISO 29993:2017 for learning services outside formal education, and ISO 29994:2021 for distance learning requirements.

These certifications ensure that the courses are designed, delivered, and assessed according to globally accepted practices for both traditional and online learning environments.

The ISO 21001 certification is issued by Business Quality Assurance International (BQAI), which is accredited by the Irish National Accreditation Board (INAB), a member of international accreditation agreements that support global recognition.

Because of this learners benefit from enhanced credibility with employers and certification bodies, consistent and high-quality course delivery, and greater confidence in the effectiveness and reliability of online learning.

Free Tools

Free ISO 14971 Risk Management Training and Certification FAQ Handbook

Free handbook answering Frequently Asked Questions about ISO 14971 Risk Management Training. Covers definition of ISO 14971, its purpose, benefits, updates, applications, etc.

Download ISO 14971 FAQ Handbook

Free Risk Assessment Tools and Methodology Guide

Table containing a guide on which risk assessment tools and methodologies are right for which job

Relying on just one approach for every situation can limit the effectiveness of your risk management process. Using ISO 31010 as a key reference for guidance, this material is designed to help you identify which Risk Assessment tool or methodology is the best fit for the task at hand.

Assess your Internal Auditor Skills

Free CPD Logbook

Make the most of your ISO Auditor training by tracking your ongoing professional development with a CPD Logbook.

Download your free copy below to record your learning, monitor your progress, and build clear evidence of your continued competence as an auditor.

Download CPD Logbook Template

Free Sample Lesson

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Choose between:

Option 1: The 5-minute Sample Lesson
Option 2: The 30-minute Free Sample Lesson

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Standard: ISO 14971	Duration: 16 hours approx.(including auditor certification exam)	Format: Online via Inquisiq	Assessment type: Certification Exam
Latest Version: ISO 14971: 2019	CPD / CEU Units: 2.7	Schedule: Self-paced, on-demand	Certificate Awarded after completion: ISO 14971 Risk Management
Revision of: ISO 14971:2007	Prerequisites: None mandatory, but previous auditing experience helps	Language: English	Course Certification: ISO 21001
Description: This advanced ISO 14971 risk management training course is designed for professionals responsible for managing and evaluating medical device risks within their organizations. Based on ISO 14971:2019 and ISO/TR 24971:2020, the course builds on foundational risk management knowledge by focusing on the practical application, selection, documentation, and evaluation of risk management methods throughout the medical device lifecycle. It also covers advanced risk analysis techniques, risk control strategies, and specialized risk management considerations, including high-risk and IVD-related situations.
Learning Outcomes: By the end of this ISO 14971 Risk Management Advanced course, you will have the knowledge and skills to: Apply the principles and requirements of ISO 14971:2019 to develop, implement, and maintain risk management processes for medical devices. Develop and manage risk management documentation, including risk management plans, risk management files, risk analyses, and residual risk evaluations. Identify hazards, hazardous situations, intended use, and reasonably foreseeable misuse scenarios to support effective medical device risk analysis and evaluation. Perform risk estimation, benefit-risk analysis, implementation of risk controls, and evaluation of residual risks throughout the medical device lifecycle. Select and apply advanced risk management methods and analytical tools, including SWIFT, PHA, FTA, ETA, FMEA, HAZOP, and HACCP techniques. Evaluate the role of ISO and IEC standards in supporting medical device risk management and regulatory compliance activities. Assess advanced and specialized risk management situations, including information security risks, legacy devices not originally developed using ISO 14971, and risk management considerations for in-vitro diagnostic medical devices (IVDs). For course content, please see below.
Related Courses ISO 14971 Risk Management Foundation – If you want to understand the core principles and requirements of ISO 14971:2019 and ISO/TR 24971:2020, with a focus on applying risk management within Medical Device Management Systems (MDMS). ISO 31010 Risk Management – Foundation (14 techniques) – If you are new to risk management and want an introductory understanding of the selection, application, and recording of 14 commonly used risk management methods and techniques. ISO 31010 Risk Management – Advanced (28 techniques) – If you already understand basic risk management concepts and want broader practical knowledge of 28 risk management methods and techniques used for more detailed risk analysis and evaluation activities. ISO 31010 Risk Management – Expert (45 techniques) – If you require extensive and in-depth expertise in selecting, applying, and documenting 45 risk management methods and techniques across complex, high-level, or specialized risk management environments.

ISO 14971 Risk Management – Advanced

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