Design Control Software
for Medical Devices
Explore medical device design control solutions that prioritize innovation, quality, and accountability, ensuring efficiency and compliance in the design process.
Maintain Your Electronic Design History File (DHF)
Grand Avenue Software’s Design Control module helps medical device manufacturers track and manage product development tasks while maintaining an electronic Design History File (DHF). This solution integrates seamlessly with our Document Control and other QMS services to streamline design control processes from start to finish.
Streamline Your Design Controls and Manage Design Projects
Our Design Control software provides visibility into the entire product development lifecycle. Tasks and deliverables are tracked by phase, created by you to align with your Product Development Plan. This ensures teams stay aligned on development goals and maintain compliance with regulatory requirements.
Maintain Design Management Files Electronically in
Real-Time
With dynamic links to Document Control, your Design History File (DHF) is automatically updated with the latest project documents and deliverables. This real-time file management ensures that your design control documentation is always accurate and accessible, reducing the risk of errors and delays.
Looking for an efficient way to manage your design control processes?
Grand Avenue Software’s Design Control module ensures compliance, traceability, and streamlined project management throughout your product development lifecycle.
Request a Demo today to see how we can help improve your design control process.
Frequently Asked Questions
Grand Avenue’s Design Control module helps manage the Product Development Process (PDP) by offering tools like design history file (DHF) management, task tracking, and phase-gate controls. It ensures that all stages of development are documented and controlled to meet regulatory requirements.
The electronic Design History File (eDHF) in Grand Avenue stores all product development documentation, from design inputs to testing and validation. It is maintained using automated version control, ensuring all changes are tracked and the file remains up-to-date throughout the development lifecycle. It is customizable for each product (you can build your phases and deliverables), and after a phase review, the screen is “frozen” at the reviewed revisions for an easy auditable eDHF.
Grand Avenue tracks product development tasks through automated workflows, assigning tasks based on project phases (e.g., design, testing, validation). The software sends notifications and reminders to ensure tasks are completed on time, helping teams manage timelines and meet regulatory milestones.
Grand Avenue offers a sample 5-phase Product Development Process (PDP) specifically for medical device companies, which includes the phases of concept, design, development, validation, and production, each with its own documentation and compliance requirements built into the system.
Grand Avenue’s Design Control module enables team collaboration through real-time review tracking, automated approval workflows, and commenting features. Team members can review and approve design documents collaboratively, ensuring all inputs are documented and tracked for compliance and traceability.
Design Control from Grand Avenue
Out-of-the-box Functionality