Reverse Engineering of Mechanical Component For Molding Process
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.
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.
Compliant documentation and improved Risk Management process.