I3CGLOBAL

I3CGlobal is a regulatory consulting firm founded in 2000, specializing in compliance services for medical device manufacturers, pharmaceutical companies, and healthcare product producers. The company supports clients navigating EU MDR/IVDR regulations, FDA 510(k) submissions, and UK regulatory requirements, with offices in Germany, India, the United Kingdom, and the United States.

The firm maintains a team of over 150 regulatory consultants organized across specialized departments including MDR technical documentation, clinical evaluation, IVDR performance evaluation, FDA 510(k) submissions, and quality management systems. I3CGlobal holds ISO 27001 certification for data security and reports completing over 3,400 projects with 24+ years of industry experience. The company provides services including technical file development, clinical evaluation reports, establishment registration, GMP consulting, and authorized representative services for non-EU manufacturers.

I3CGlobal positions itself as a partner for healthcare product manufacturers seeking to enter or maintain compliance in European and US markets, with particular focus on medical device regulations and pharmaceutical documentation requirements.

I3CGlobal makes sense for healthcare product manufacturers navigating complex multi-jurisdictional regulatory requirements, particularly those needing simultaneous support for EU and US market entry. The firm's departmentalized structure means clients work with specialists focused exclusively on their specific regulatory pathway rather than generalists.

Companies can expect structured project management with cloud-based documentation delivery and dedicated team assignments. The firm's provision of statutory services like EU Authorized Representative and UK Responsible Person roles offers a single-vendor solution for manufacturers establishing European market presence.

I3CGlobal operates exclusively within healthcare regulatory compliance, focusing on medical devices (all classes), in-vitro diagnostics, pharmaceutical products, and FDA-regulated healthcare products. The firm's entire operational structure—from its 30-person clinical evaluation team to its specialized IVDR performance evaluation department—is built around healthcare product regulatory requirements.

The company addresses healthcare-specific compliance needs including MDR Article 61 clinical evaluations, FDA 510(k) premarket notifications, EU MDR technical file development, and IVDR performance evaluations. Their ISO 27001 certification directly supports HIPAA and medical data security requirements common in healthcare regulatory work.

International medical device manufacturers entering European or US markets for the first time, established healthcare product companies expanding into new regulatory jurisdictions, and in-vitro diagnostic producers navigating the transition to EU IVDR requirements. Companies seeking comprehensive regulatory documentation support alongside authorized representative services find particular value in I3CGlobal's integrated service model.