ISO 14971:2019 Risk Management – Advanced Course Content

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.

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
• Option to pay in 4 monthly installments available

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

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

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

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.