I3CGLOBAL, a global regulatory consulting leader, has expanded its team of IVDR consultants to supportIndian in vitro diagnostic (IVD) manufacturersin meeting the EU IVDR 2017/746 compliance deadline by 2028.
With the European Union tightening requirements for CE Marking under the new IVDR, Indian manufacturers face mounting documentation and performance evaluation challenges. To address this, we have strengthened its technical manpower, improved internal efficiency, and optimized its consulting workflow for faster and more predictable results.
“Our expanded team of IVDR consultants ensures that Indian IVD manufacturers can meet the 2028 EU deadline without unnecessary delays,” said Soio George, Project Head at I3CGLOBAL. “We are focused on delivering efficient, high-quality technical documentation and compliance strategies that save both time and cost.”
Major Scope of IVDR Consultants
- IVDR Gap Assessmentand compliance strategy
- Technical Documentation (TD) and
- Performance Evaluation Reports (PER)
- Clinical and analytical performance studies
- Notified Body application support and coordination
- Post-Market Surveillance (PMS)and PMPF documentation
- European Authorized Representative Service
With proven experience in CE Marking and regulatory consulting and continues to be a trusted partner for IVD manufacturers preparing for EU market compliance.
About I3CGLOBAL
I3CGLOBAL is a global regulatory consulting firm specializing in Medical Device and In Vitro Diagnostic (IVD) CE Marking, FDA 510(k) submissions, and QMS compliance. Established in 1999, the firm has supported over 1,500 manufacturers worldwide with expert documentation, regulatory strategy, and market access solutions. For more information, visit www.i3cglobal.com or contact enquiry@i3cglobal.com.
