About Us
Who We Are: Experts in Medical Device Regulatory Compliance
At Medestan Consulting, we provide specialized expertise in regulatory submissions and industry standards compliance for medical device manufacturers. Our team is dedicated to streamlining FDA 510(k) submissions, EU MDR technical files, and global market access strategies. With deep knowledge of risk management, usability engineering, and compliance with standards like IEC 60601-1 and IEC 62304, we help bring safe, high-quality devices to market with confidence.
What We Do: Turning Regulatory Complexity into Market Success
We don’t just consult—we partner with you to navigate the challenges of regulatory compliance. Our expertise in FDA submissions, EU MDR compliance, and global regulatory strategies ensures your medical devices meet industry requirements and thrive in competitive markets. From regulatory planning and gap analyses to technical documentation and standards compliance, we deliver tailored solutions that drive successful approvals.
How We Do It: A Client-Focused, Results-Driven Approach
Your vision is our priority. Through customized consultancy, we provide strategic regulatory guidance, risk-based compliance solutions, and seamless documentation support. Our collaborative approach ensures every step aligns with your business goals, enabling faster approvals and a clear path to market entry.