Design Control & DHF/DMR
Build robust design controls that satisfy FDA requirements and accelerate product development.
The Challenge
Common pain points that prevent medical device manufacturers from achieving sustainable compliance.
Incomplete Design History
Missing design inputs, outputs, and verification records causing FDA submission rejections.
Documentation Chaos
Design documents scattered across systems, making it impossible to demonstrate design control compliance.
Verification Gaps
Unclear verification and validation protocols leading to design control deficiencies.
The VigilaMed Solution
Complete Design Control Implementation
We establish comprehensive design control systems with proper DHF/DMR structure. Every design input, output, verification, and validation is documented and traceable.
Manufacturing-First Methodology: Our structured approach ensures your design controls meet FDA 21 CFR Part 820.30 requirements while maintaining development velocity. No compliance bottlenecks.
What You Get
Tangible deliverables that deliver immediate value and long-term compliance.
- Design Control Procedures (SOP)
- Design History File (DHF) Structure
- Device Master Record (DMR) Template
- Design Input/Output Templates
- Verification & Validation Protocols
- Design Review Meeting Framework