The Path to Compliance
We've refined our methodology over decades to ensure a smooth, predictable journey for your medical device.
Discovery & Strategy
We start by listening. We analyze your device, your target markets, and your business goals. Then, we build a custom regulatory roadmap that outlines the most efficient path to market, identifying potential pitfalls before they become problems.
- Regulatory Strategy Report
- Classification Confirmation
- Project Timeline & Budget
- QMS Gap Analysis
- Technical File Remediation
- Risk Management (ISO 14971)
Execution & Remediation
This is where the work happens. We roll up our sleeves and close the gaps. Whether it's writing SOPs, conducting risk assessments, or compiling technical documentation, we ensure every document is audit-ready and compliant with the latest standards.
Submission & Audit
We prepare your final submission package (510(k), Technical File, etc.) and support you through the review process. If an audit is required, we help you prepare, participate in the audit, and respond to any findings. We don't leave your side until the certificate is in hand.
- Submission Packet Ready
- Audit Preparation Training
- Response to Reviewer Questions
- Post-Market Surveillance
- Change Control Management
- Internal Audits
Maintenance & Growth
Compliance is not a destination; it's a journey. After approval, we help you maintain your system, manage changes, and handle post-market surveillance. We act as your long-term regulatory partner, ensuring you stay compliant as you grow and evolve.
Ready to Start Your Journey?
Let's discuss where you are in the process and how we can help you get to the finish line.
Schedule Your Discovery Call