Ensure product design & development processes are systematically planned, executed, and documented, meeting regulatory requirements and enhancing product quality.
Integrated Design Reviews
Facilitate thorough design reviews with links to verification, validation, and design output documents for comprehensive assessment.
Automated Documentation
Generate and link design history files (DHF), device master records (DMR), and other critical documents automatically, streamlining regulatory submissions and audits.
Customizable Workflows
Generate and link design history files (DHF), device master records (DMR), and other critical documents automatically, streamlining regulatory submissions and audits.
“If we didn’t have Unifize, it would create a disaster we would have to start from scratch on so many things.”