Design Control

Design and development is a collaborative process with many moving parts. With ClearMark’s unique Design Control workflow, team organization, communication, and collaboration have been completely reimagined. ClearMark compiles and displays your records to ensure your project stays organized and accessible to your team. With automatic DHF compilation, records and documents have never been easier to access or audit, ensuring compliance during your product development process and beyond.

Design Control Feature List

More than just a requirements tracker, ClearMark provides the only electronic Quality Management System with Design Controls specifically for medtech from concept through design transfer. ClearMark focuses on design and development compliance, so you can focus on the safety and efficacy of your product.

New Product Design and Development

Take your product from concept through transfer

Engineering Changes

Modify existing products in the same user-friendly workflow

Project Planning

Plan projects in accordance with the regulations and standards

Team Organization

A digital coworking space to ensure team members have real time access to project information

Automatic DHF Compilation

Automatically compile your DHF as part of your design control workflow

Design Reviews

Industry first TDR workflow with attendance, file uploads and approvals

Record Generation

Automatically launch your documents as record in your design control process

Custom Approvals

Leverage ClearMark’s proprietary approval process workflow – configure users at any level for any phase of the project

Industry First Design Control Timeline

Track your projects from concept through design transfer with automatic progress tracking and full team visibility