There are 2 Courses available for the effective Risk Management of Medical Devices
One of the primary reasons for the revision and extension of the ISO 14971 Standard in 2019 was to extend the application of risk management tools beyond the blanket application of FMEAs alone to the protection of patient and end-user safety. Two examples of where other tools are far more appropriate would be ...
- the use of PHA - Preliminary Hazard Analysis in the planning stage of new product design and development and
- the use of HACCP - Hazard Analysis and Critical Control Point in ensuring and recording the control of critical stages in the manufacture of a medical device.
We have prepared two Courses to help you in adequately and effectively auditing and implementing the ISO 14971:2019 Standard and a quick overview of the Course Content is given below. Both Courses come with extensive examples, charts and process diagrams and, with the Advanced Course, a comprehensive set of Templates. As with all deGRANDSON Courses, these ones are available on-demand, self-paced and delivered online (including the examinations).
Course 723: ISO 14971 Medical Device Risk Management – Foundation
This 8-hour 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.
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 and includes …
- Risk Management Process
- Management Responsibilities
- Qualification of Personnel
- Risk Management Plan
- Risk Management File
- 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
Course 724: ISO 14971 Medical Device Risk Management – Advanced
This 16-hour course is for those wishing to manage medical device risk for their companies and is also based on ISO 14971:2019 and ISO/TR 24971:2020.
It is a comprehensive Course covering the selection, application and recording of Risk Management methods and 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
- 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
- Module 3: Advanced Risk Management including …
- Risk Acceptance
- Risk Control
- Risk Evaluation
- Special Risk Situations including IVDs
If you have any questions, please contact us. We're always delighted to help.
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