Our Services
The path to market looks different for everyone. Whether you need a quality management system audit or regulatory compliance consulting, we are here as your partners. Your goals are our goals, and we will equip you with a plan and strategy tailored to your specific needs.
FDA Submission Preparation and Filing
Borderless MedDev helps you build a strong, strategic case for FDA clearance. We ensure each submission meets FDA standards and clearly presents your device’s safety. performance and intended use.
From there, we partner with you throughout execution, working directly with test houses and regulators, handling communications, and supporting your team. We create high-quality submission portfolios designed to stand up to review and accelerate your path to market.
FDA Clearance Remediation
Even with careful preparation, 510(k) applications do not always go as planned. You might receive unexpected feedback, requests for additional data, or confusing guidance that can stall your progress. If you don’t have regulatory experience, it’s easy to feel overwhelmed and uncertain about the way forward.
That’s where we come in.
Borderless MedDev specializes in helping innovators navigate these challenges with clarity and confidence. Whether you're preparing for 510(k) or remediating a stalled submission, we will guide you from start to finish.
Quality Management System (QMS) Support
Our team provides training, fractional quality leadership, and ongoing support to keep your operations running strong. Our services include:
Supplier quality audits
Risk assessments and monitoring
Corrective and preventive action (CAPA) support
Documentation reviews and compliance checks
Our extensive experience ensures your supply chain stays strong and aligned with your goals.
Quality Management System (QMS) Development
Borderless MedDev offers hands-on training to ensure your internal teams understand and meet FDA requirements. Our experts equip your staff with the knowledge and tools they need to keep your system running smoothly and your entire organization aligned.
We ensure alignment with:
FDA QMSR (21 CFR Part 820)
ISO 13485
Regulatory requirements for medical devices and QMS
MDSAP and other international frameworks