AssurX Design Control Solution helps maintain design controls as living documents while integrating risk management at vital steps in the process through automation to ensure medical devices product safety and compliance.

• Full traceability of requirements and deliverables within the Design History File (DHF)
• Addresses the Risk Management Process
• Track tasks and streamline project management
• Efficiencies in post market surveillance and design change processes including submission of electronic Medical Device Reporting (both 3500A and EU MIR)

WHY IS DESIGN CONTROL SO IMPORTANT?

Design Control Software is crucial for medical device manufacturers to comply with regulatory requirements, like FDA regulations. This software helps manage the design process efficiently by organizing and documenting design inputs, outputs, reviews, and changes. It provides a systematic approach to design control activities, improving traceability, transparency, and accountability. By implementing the software, manufacturers can streamline design processes, reduce errors, and mitigate risks linked to design changes.

Having robust Design Control Software not only ensures regulatory compliance but also enhances product quality, safety, and reliability. This contributes to improved patient outcomes and market competitiveness.

To see the Design Control Solution demo, connect with us today to get started!