Design Control Software

Maintain design control processes from initial planning through design transfer

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:

AssurX Design Controls provides for full traceability of requirements and deliverables
  • 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

AssurX Design Control Solution Video Demo

Watch a 10 Minute Video of the AssurX Design Control Solution Now

Learn how the AssurX Design Control Solution maintains records as living documents while integrating risk management at vital steps in the process through automation.

“Amazing system with endless configurable possibilities!”

The most helpful part of AssurX is the ability to configure it to our company needs. The biggest upside has been the ability to do away with the paper-based format we had…read the rest.

Jose C.
Quality System Software Administrator

“Very flexible and powerful”

With AssurX you can easily configure forms and workflows using the graphical tools provided.You can connect to multiple data sources quite easily. Their Professional Services team is full ofread the rest.

Sal D.
Principal Consultant

“I highly recommend AssurX as an EQMS system!”

AssurX is a Highly Configurable product and the Configuration specialist are very responsive. Using the Dev site as a template you can test out everything before migrating over...read the rest.

Natalie P.
Quality System Software Administrator

AssurX: Quality & Compliance Systems for Every Enterprise

The quality and compliance journey can be an obstacle course of changing regulations and standards in a dynamic global market. The AssurX enterprise quality management system (EQMS) and the AssurX Energy Compliance System (ECOS) help guide organizations through the complexities of any regulatory landscape.

Our dynamic, connected quality and compliance management solutions help guide your journey by automating processes to streamline event management, minimize risk, measure performance and facilitate change. The result is a proactive system that improves efficiency, compliance readiness, product quality, and customer satisfaction.

Helpful equipment tool
Robotic arms
Wind turbines turning
Glass bottles stacked next to each other
Fan turning-Training Management Software Solution Powered by AssurX QMS
Helpful equipment tool -Training Management Software Solution Powered by AssurX QMS

One Platform. Every Solution.

AssurX centralizes quality management and regulatory compliance processes within a single, configurable software platform. The system includes core quality and compliance workflows out of the box, eliminating the need for separate modules and reducing reliance on paper-based or disconnected systems.

Organizations can deploy the solutions they need today and add additional capabilities as requirements evolve. With pre-configured workflows, searchable data, and flexible integration options, AssurX supports efficient deployment, configuration, and long-term scalability across the enterprise.

Audit Management

CAPA Management

Calibration Management

Change Management

Complaint Management

Customer Quality Management

Deviation Management

Document Management

EHS Incident Management

Nonconformance Management

Quality Management Review

Risk Management

Supplier Quality Management

Training Management

Validation Management Solution