Design Control

Overview

The Design Control software is crafted to assist MedTech teams in managing product development with precision and compliance. It provides a unified platform to maintain a real-time Design History File (DHF), align with the Product Development Plan (PDP), and ensure traceability from concept to approval.

Key Features

• Real-Time DHF Management: Automatically updates and links documentation to keep the Design History File current, enhancing accuracy and audit readiness.
• Product Development Plan (PDP) Management: Utilize built-in templates to define and manage your PDP, assigning roles and deliverables by team, project, and phase.
• Phase-Based Tracking: Monitor tasks and deliverables through phase-based tracking, ensuring alignment with the PDP and regulatory compliance.
• Automated Workflows: Assign tasks based on project phases with notifications and reminders to ensure timely completion and adherence to regulatory milestones.
• Team Collaboration: Facilitate collaboration with real-time review tracking, automated approval workflows, and commenting features.

Benefits

By using this software, teams gain full visibility into the product development lifecycle, ensuring coordination and milestone achievement. The platform reduces manual overhead, improves collaboration, and maintains audit-ready documentation.

Compliance and Customization

The software supports a customizable electronic Design History File (eDHF) that tracks all product development documentation, from design inputs to testing and validation. Automated version control ensures all changes are tracked, and the file remains up-to-date throughout the development lifecycle. The system offers a sample 5-phase PDP tailored for medical device companies, covering concept, design, development, validation, and production phases.

Overall, this software streamlines design control processes, enabling MedTech teams to align faster, collaborate more effectively, and maintain compliance from concept to commercialization.