Simplicity and ease-of-use in Risk Management
Based on the regulatory requirements on Safety Risk Management, the medical device industry invested a considerable amount of time and efforts to generate and maintain risk management documentation. We should now be ready for the next step, to turn these investments into value adding tools and to make them easier-to-use for engineers. This presentation will show how to simplify risk management and how to use the information more effectively while carefully avoiding overloaded and non-sustainable quality systems.
Templates for Safety Risk Management
The attached templates may be used for Risk Management activities. Trainings are available for including workshops.
Attached files:
Template Risk Management File
Combining FMEA and HACCP
Simplicity and ease-of-use in Risk Management
Template Risk Management Plan
Template Usability Checklist
Template Risk Management Report
Template Risk Analysis (FTA type)
Template Risk Analysis (HA-FMEA type)
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