AssurX's design control software for medical devices integrates quality practices into the design and development process. It ensures compliance with industry regulations, manages risk, and streamlines project management. The software maintains records as living documents, enhancing traceability and efficiency.
Vendor
AssurX
Design Control Software
Medical device manufacturers need to have quality practices and procedures incorporated in their product’s design and development process to ensure that the device is appropriate for its intended use. AssurX Design Control software is a product lifecycle management solution. The capabilities allow users to address and manage the risk management process and track tasks to streamline project management while complying with industry regulations.
AssurX Design Control Benefits include:
- Allowing for full traceability of requirements and deliverables, addressing the following areas required to be documented within the Design History File:
- Design and Development Planning
- Design Input
- Design Output
- Design Review
- Design Verification
- Design Validation
- Design Transfer
- Design Changes
- Addressing and managing the risk management process.
- Enabling the ability to track tasks and streamline project management.
- Quickly and seamlessly adding related documents from document management repository.
- Easily generating reports including all design history file (DHF) information
