Risk Management - Escentia

Risk management for medical devices – your personalized safety cockpit

Medical devices must be safe.

The focal point for safety is risk management. All safety-relevant data comes together in this process. Unfortunately risk management is often displayed in a bad light. The process is known for documenting absurd and unlikely events in an excel spreadsheet. It is known for being a legal insurance and as a storage area for topics that do not really fit anywhere but must be documented. But risk management is not being known for ensuring safety.

It doesn’t need to be that way. We are the gardening service for abandoned risk management systems. We clean up the risk management file, cut away all not necessary information and reduce it to only safety-relevant content.

What we offer:

Risk management according to ISO 14971
Review of risk management file
Review of risk management system

Basic training for members of the risk management team
Advanced training for risk managers
Individual coaching and support for risk management activities

Safety through simplicity. Excellence through simplicity.

Safety

We make sure that your documentation is representing your device and that the risk management file is your cockpit for controlling safety. We make sure that you can act before you are forced to react.

Simplicity

Regulations are complex enough. We make sure that your risk management system adds value and is interconnected within the quality management system. It does not add any value if the process is compliant but not being followed.