ISO 14971:2019 Foundation Course Content

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.

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

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

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 ISO 14971 Risk Management – Foundation 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 this ISO 14971 Risk Management – Foundation 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

Are there any prequalifications to enroll in this ISO 14971 Risk Management – Foundation 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.