Full Service CRO for Medical Device Global Entries.

Our global CRO business stands as a beacon of innovation and reliability. With a focus on precision, efficiency, and foresight, we are committed to revolutionizing the journey of medical device market entry through the seamless integration of strategic consultancy and unparalleled industry proficiency.

Medical Devices we focus on

Medical Instruments

We specialize in delivering top-tier regulatory submission services tailored for medical device instruments. With an intricate understanding of the ever-evolving regulatory landscape, our dedicated team ensures a seamless and compliant submission process. We prioritize precision and efficiency, guiding you through the intricate steps of regulatory compliance to accelerate your product's journey from concept to market, all while upholding the highest industry standards.

In Vitro Diagnostic Reagents

Navigating the complex realm of regulatory submissions for In Vitro Diagnostic (IVD) reagents demands expertise and precision. We excel in providing comprehensive regulatory submission services specifically designed for IVD reagents. Our seasoned professionals possess a deep comprehension of the regulatory nuances, streamlining the submission process to ensure compliance and facilitate a swift path to market approval. Trust us to be your strategic partner in securing regulatory clearance, enabling you to focus on innovation while we handle the compliance intricacies.

Regions we focus on

FDA Compliance

Navigating the regulatory landscape of the United States is paramount, and Mecca excels in meeting the rigorous standards set by the FDA. Our Regulatory Affairs team has extensive experiences in FDA requirements, ensuring that your medical devices not only meet but exceed the expectations of this gold standard regulatory body.

CE Mark

For market access in the European Union, our Regulatory Insights experts facilitate the CE marking process. We understand the intricate requirements and nuances of European regulations, and our team ensures that your medical devices comply with the essential health and safety requirements. Mecca acts as your strategic partner, guiding you through the CE marking journey with precision and expertise.

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