Reverse Engineering of Mechanical Component For Molding Process
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.
Finite Element Simulation on Dental Implant According to ISO 14801
Biological Evaluation of Dental Device