ISO 14971:2019 Risk Management 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.
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
This comprehensive Course covering all aspects of medical device risk management is divided into four Modules …
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- 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
- 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
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
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
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.
Not sure this is the best ISO 14971 Course for you?
Check out our ISO 14971 Medical Device Risk Management – Foundation course for comparison or see our answers to frequently asked questions about ISO 14971.
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