FDA 21 CFR Part 820 Compliance
Navigate FDA regulations with confidence and achieve first-time submission success.
The Challenge
Common pain points that prevent medical device manufacturers from achieving sustainable compliance.
Regulatory Complexity
Understanding FDA requirements and ensuring design controls meet 21 CFR Part 820 standards.
Design Control Gaps
Missing or incomplete design history files (DHF) and device master records (DMR) causing submission delays.
Inspection Readiness
Preparing for FDA inspections without knowing what they'll examine or how to respond.
The VigilaMed Solution
FDA 21 CFR Part 820 Compliance Program
We implement comprehensive FDA compliance systems covering design controls, production processes, and quality assurance. Your pathway to successful 510(k) submissions and inspection readiness.
Manufacturing-First Methodology: Our FDA expertise ensures your design controls, DHF/DMR structure, and production processes meet FDA expectations. We prepare you for every inspection scenario.
What You Get
Tangible deliverables that deliver immediate value and long-term compliance.
- Design Control Procedures (21 CFR 820.30)
- Device History File (DHF) Structure
- Device Master Record (DMR) Template
- FDA Inspection Preparation Guide
- 510(k) Submission Support Documentation
- CAPA System (FDA Compliant)