Who should enrol in this course?

This ISO 14971 training course is intended for those who: need to plan and conduct an internal audit medical device risk management for their organization, wish to offer consultancy support in MDMS, you are Management Representative for their organization and are the Audit Programme Manager for MDMS internal audits. wish to improve your career prospects.

What will I learn from this course?

This comprehensive ISO 14971 training course covers all aspects of medical device risk management is divided into four Modules … 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

What course materials are included in the course?

This ISO 14971 training course includes 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

ISO 14971:2019 Foundation Course Content

Name: ISO 14971 Medical Device Risk Management - Foundation
Brand: deGRANDSON
SKU: Course 036
Price: 1200 GBP
Availability: InStock

Be an internationally-certified Medical Device Risk Management Internal Auditor with this ISO 14971 training course.

It provides you with the Tools, Skills and Knowledge necessary to plan and audit a Risk Management Programme for your medical device (or component) manufacturing organization.

Who Should Enroll in this course?

This ISO 14971 training course is intended for those who:

need to plan and conduct an internal audit medical device risk management for their organization,
wish to offer consultancy support in MDMS,
you are Management Representative for their organization and are the Audit Programme Manager for MDMS internal audits.
wish to improve your career prospects.

What does the course cover?

This comprehensive ISO 14971 training course covers all aspects of medical device risk management is divided into four Modules …

- 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
- 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

What materials are included in this course?

This ISO 14971 training course includes 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

How is the course delivered?

This ISO 14971 training course is 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

What Previous Qualifications are Required for the Course?

For this foundation 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 is recommended.

A knowledge of ISO 13485 would be an advantage but not necessary.

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.

Not sure this is the best ISO 14971 Course for you?

See our list of available risk management courses, our answers to frequently asked questions about ISO 14971 , or ISO auditor training in general.

Related Courses

ISO 13485 Training Courses

ISO 45001 Training Courses

ISO 13485 Requires Risk Management & Risk-based Thinking

ISO 45001 requires Risk Management & not just Risk-based Thinking

Risk Management in ISO Management System Standards

Frequently Asked Questions

Is the Program Certified?

Yes, deGRANDSON is an ISO 21001 certified educational organization certified by BQAI, an internationally accredited certification body.

ISO 21001 is a university grade standard used globally by schools, colleges, and universities. We are also certified to ISO 29993: 2017 (Learning services outside formal education and Service requirements) and ISO 29994:2021 (Education and learning services; Requirements for distance learning).

Are there corporate discounts?
Yes, details of discounts, based on numbers enrolled, can be found on the Corporate Discounts page.

How can I pay?
You can pay by Debit Card, Credit Card or PayPal during the Program Enrolment procedure. Click on this link to view the Payment Process.

Is there an Examination?
Yes. In addition to the Quizzes at the end of each Module, there is at the end of each Course (set of Modules/Lessons) a formal Examination. The decision to award a Certificate is based on the combined scores achieved. The Examinations are open-book (you can have the Standard and other notes open beside you), time-limited and taken online. There are no extra costs involved.

What do I get when I’ve completed the Program?
Once you have completed the Examination, your Certificate is immediately available to you. Your Certificate will be forwarded to you as an email attachment that you may print as often as you like. There is no time limit on the validity of your Certificate.

What else will I need to become a competent auditor?
Provided you have the required personal attributes, all you need to add is auditing experience.

Who can I contact for more information?
Just send an e-mail to [email protected] or, for other options, see Contact Us.

Standard: ISO 14971 Latest Version: ISO 14971: 2019 Revision of: ISO 14971:2007	Duration: 8 hours approx. (including auditor certification exam)	Delivery: Online (on-demand and self-paced) CPD Units: 1.3
Description: This Online Course is for those wishing to audit medical device risk for their companies and is based on ISO 14971:2019 and ISO/TR 24971:2020.
Course Content It is a detailed Course covering a wide variety of Risk Management methods and is divided into three Modules: 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 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 For each risk assessment tool completed examples are provided. On completion, you will be able to audit against the requirements of ISO 14971 as part of your ISO 13485 Programme of Internal Audits. For Course Content details and a list of Course Materials see below.
Related Courses: ISO 14971 Risk Management Course (Advanced) – if you want more comprehensive training covering the selection, application and recording of Risk Management methods.

ISO 14971 Risk Management – Foundation

ISO 14971:2019 Foundation Course Content