Manages regulatory and compliance requirements for:
Materials utilized to promote, advertise and educate people about products must have strict quality and version control
Any medical device’s traceability must be documented in a Device History Record (DHR).
The history and information on how you made the device in accordance with the Device Master Record (DMR) is stored in the DHR that contains the necessary specifications for building and testing a device, demonstrating the device was manufactured according to the information in the DMR to required FDA standards.
Procipient® facilitates meeting FDA standards by providing Intuitive, centralized document management with powerful reporting.
Executes Risk Analysis with:
Simplifies Risk Management by: