IVDR Consultants at I3CGLOBAL Empower Indian IVD Manufacturers to Achieve CE Marking before 2028 deadline

“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.