Challenge

The customer needed to remedediate the Risk Files of Implantable class IIb device and Instruments to be compliant with the EN ISO 14971:2012 standard.

Solution

We perform a gap analysis of existing documentation. We define and implement a new SOP and process. We worked with the client to remediate and improve the existing documentation.

Our Results

Compliant documentation and improved Risk Management process.

100%

Quick Service

100%

Customer Satisfaction

risk-management