🚀 Welcome! Let’s Get You FDA-Ready
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Ready to Enter the U.S. Market? Let’s Make it Simple.
Expanding into the United States means huge growth potential — but also complex FDA regulations.
At Compliance Insight, we make the process clear and manageable. Whether you’re preparing your first 510(k) submission, navigating FDA inspections, or implementing a compliant quality system, our experts will guide you every step of the way — with speed, clarity, and confidence.
Grab you 510(k) Submission Checklist..
Download the Checklist_English
See How Other Manufacturers Succeeded
Case Study 1: Selecting a Predicate Device for a 510(k) Submission
A mid-sized Chinese manufacturer partnered with us to complete their U.S. regulatory submission — and entered the market faster than competitors.
(Read Full Story →)Case Study 2: Product Code selection is Key
One of our clients faced a surprise FDA inspection. With our preparation and mock audit support, they passed with no Form 483 issued.
(Read Full Story →)Case Study 3: Inadequate Laboratory Data for 510(k) Submission
A startup transitioned from local standards to full U.S. GMP compliance — setting them up for long-term success.
(Read Full Story →)- Case Study 4: False Positives in AI_powered Software as a Medical Device (SaMD)
A digital health startup faced a wave of user backlash after their AI-powered software triggered false-positive alerts for serious conditions. With Compliance Insight’s guidance on validation and documentation, the company re-launched their product — this time with trust restored.
(Read Full Story →)
- Case Study 5: AI System Breach in Combination Product Supply Chain
After a cyberattack compromised sensitive data in their AI-driven logistics system, a combination product manufacturer turned to us. We helped contain the damage, supported CAPA efforts, and safeguarded regulatory standing.
(Read Full Story →)
- Case Study 6: Compliance vs. Shortcuts in ECG Monitoring Manufacturing
Two ECG monitor manufacturers took different paths. One followed FDA requirements with Compliance Insight’s support. The other cut corners. Only one passed their FDA inspection and built long-term market trust.
(Read Full Story →)
🛠️ Our Core Services
We help medical device manufacturers navigate FDA compliance with confidence:
FDA 510(k) Submission Strategy & Execution
U.S. Agent Representation & FDA Registration
Quality System Setup & Alignment (21 CFR Part 820 / ISO 13485)
Mock FDA Inspections
Remediation for Warning Letters & 483s
Let’s Talk – Your First Consultation is Free
Not sure where to start?
Book a no-obligation call with one of our FDA regulatory experts. We’ll help you evaluate your readiness and map out your next steps.
Contact us at: 00 1 513-860-3512 or info@compliance-insight.com