https://www.taxtmi.com/news?id=67810 Indian IVD makers confront data shortfalls, study design and site access constraints, fragmented IVDR expectations, resource limitations, and heightened post market evidence demands that delay CE marking. Reghelps SRC proposes a comprehensive remediation package-protocol design, clinical site and study management, biostatistics, regulator aligned dossier preparation, post market surveillance planning, and capacity building training-intended to produce submission ready performance evidence, mitigate regulatory risk, and speed IVDR CE marking and market access. en-us Mon, 19 Jan 2026 17:01:04 +0530 Mon, 19 Jan 2026 17:01:04 +0530 TaxTMI RSS Generator https://www.taxtmi.com/news?id=67810 Indian IVD makers confront data shortfalls, study design and site access constraints, fragmented IVDR expectations, resource limitations, and heightened post market evidence demands that delay CE marking. Reghelps SRC proposes a comprehensive remediation package-protocol design, clinical site and study management, biostatistics, regulator aligned dossier preparation, post market surveillance planning, and capacity building training-intended to produce submission ready performance evidence, mitigate regulatory risk, and speed IVDR CE marking and market access. News - Mon, 19 Jan 2026 17:01:04 +0530 https://www.taxtmi.com/news?id=67810