MEDESTAN CONSULTING
Expert Insight, Flexible Strategies: Your compass for Medical Device Compliance
Medestan Consulting: Your Partner in Medical Device Regulatory Compliance
At Medestan Consulting, we provide end-to-end regulatory solutions to help medical device manufacturers navigate complex compliance requirements and achieve market success. We specialize in FDA 510(k) submissions, EU MDR technical files, and global market access strategies, ensuring a clear path from development to market approval.
With expertise in industry standards such as IEC 60601-1, IEC 60601-1-2, IEC 62304, and IEC 62366-1, we ensure compliance through tailored regulatory strategies, gap analyses, and technical documentation support. Our team streamlines approvals and optimizes product development, helping you bring safe, high-quality devices to market.
Regulatory Expertise at Every Step
Our specialized services guide you from concept to market approval, ensuring compliance with global safety and performance standards. We simplify submissions and help you navigate regulatory requirements with confidence.
With over 25 years of industry experience, Medestan Consulting ensures regulatory success and accelerates market entry. Partner with us to drive innovation, maintain compliance, and secure your competitive edge in the global medical device industry.