Accelerating Access to Medical Innovations for Patients Worldwide.
Global Market Access Starts With Us
We’re Borderless MedDev, seasoned experts helping medical innovators bring their devices to market. The regulatory landscape is complex, filled with strict requirements and details that can delay patient access to cutting-edge technologies. Borderless MedDev guides manufacturers through these challenges with clarity and expertise.
In an industry built on truth and accuracy, we hold ourselves to the same standard. We’re more than just advisors. We act as partners, coaches, and advocates for our clients. Together, we accelerate access to medical innovations for patients worldwide.
The Possibilities are Borderless
We ensure your medical innovations are ready for any market, domestic or global.
FDA Submission Prep and Filing
From regulatory strategy to final clearance, we help you craft a clear, compelling case for the FDA. Borderless MedDev develops customized regulatory plans and creates high-quality eSTAR submission portfolios, setting you up for your best chance at clearance. We even manage pre-submission meetings and formal responses.
FDA Clearance Remediation
When a 510(k) submission hits unexpected roadblocks, we step in. Borderless MedDev helps medical device companies communicate with the FDA, plan acceptable responses, and get back on track. With years of experience in remediation, we work directly with the agency to secure the clearances our clients need.
Quality Management System (QMS) Support
Comprehensive audits set the foundation for sustained compliance and operational excellence. Our team provides training, fractional quality leadership, and ongoing support to keep your operations running strong. We lead internal and supplier audits to thoroughly review all procedures, identify issues, and implement solutions.
Quality Management System (QMS) Development
Borderless MedDev builds flexible, standards-aligned QMS solutions tailored to your stage and strategy. Whether you need support with FDA QMSR, ISO 13485, MDSAP or other international frameworks, we implement what you need, when you need it.
Why Borderless MedDev?
Our consultants wrote the book, literally. With decades of industry experience, our team has brought countless devices to market and helped shape key standards, including IEC 60601-1. We have navigated the compliance process from every angle, and now we are here to share what we have learned with you.