IVDR 2017/746 CE Marking new Stratigies from I3CGLOBAL

I3CGLOBAL, a leading global regulatory consultancy for medical devices and in vitro diagnostics (IVDs), announces the launch of its new strategies for IVDR 2017/746 CE Marking. These strategies are designed to help IVD manufacturers worldwide navigate the increasingly complex regulatory landscape under the European Union's In Vitro Diagnostic Regulation (IVDR).

With the IVDR introducing stricter requirements for performance evaluation, clinical evidence, and conformity assessment, I3CGLOBAL's enhanced approach focuses on streamlining compliance, optimizing documentation, and reducing time-to-market. The consultancy leverages a team of experienced regulatory experts, including specialists in clinical evaluation, quality management, and performance studies, to deliver comprehensive IVDR CE Marking support.

"Our new strategies are tailored to meet the evolving IVDR requirements while helping manufacturers minimize costs and avoid regulatory setbacks," said Mr. Soio George, Project Head for Medical Devices. "We guide clients through the entire CE Marking process-from performance evaluation planning to final submission-ensuring compliance with IVDR 2017/746 and a smooth market entry in the EU."

I3CGLOBAL continues to provide end-to-end regulatory support, including conformity assessments, Notified Body interactions, and post-market surveillance guidance, making it a trusted partner for IVD manufacturers globally.

About I3CGLOBAL:
Since 1999, I3CGLOBAL has successfully supported over 1,500 CE Mark approvals and 180+ FDA 510(k) clearances for medical devices and IVDs worldwide. The company specializes in regulatory strategies, clinical evaluation, quality management, and compliance consulting for manufacturers seeking global market access.

I3CGLOBAL U.S INC
1914, J N Pease Pl, Charlotte, North Carolina, 2826, USA

I3CGLOBAL offers expert IVDR CE Marking solutions, helping IVD manufacturers ensure compliance, reduce timelines, and optimize performance evaluation processes.

This release was published on openPR.