Design Control
Keep Development on Track. Stay Compliant.
The Design Control module helps MedTech teams drive product development with clarity and control. Maintain a real-time Design History File (DHF), align with your Product Development Plan (PDP), and ensure full traceability from concept through approval in one connected platform.
Built for Traceability and Team Accountability
Streamline Your Design Control and Drive Project Success
Gain full visibility into the product development lifecycle with phase-based tracking of tasks and deliverables. Align work with your Product Development Plan to keep teams coordinated, meet milestones, and ensure regulatory compliance—every step of the way.
Keep Your DHF Current with Real-Time File Management
With built-in links to Document Control, your Design History File (DHF) stays up to date automatically—ensuring the latest project documents and deliverables are always reflected. This real-time visibility improves accuracy, reduces delays, and simplifies audit readiness.
Looking for an efficient way to manage your design control processes?
Grand Avenue Software’s Design Control module helps MedTech teams align faster, collaborate more effectively, and maintain audit-ready documentation—without the manual overhead. Ensure compliance, track progress, and keep your DHF accurate in real time.
Request a Demo today to see how Grand Avenue can streamline your design controls from concept to commercialization.
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.