Indegene provided CE Marking Registration support per the IVD Directive for a leading Indian healthcare company marketing medical devices in the EU, achieving 100% technical dossier accuracy, zero review comments from the notified body, and CE certification in just 1 week. Needs included EU CE Marking for multiple COVID-19 test kits, gap assessment and remediation of technical documents, appointing an EU authorized representative, and end-to-end consulting. Indegene's specialized software automated dossier compilation, conducted precise gap analyses, standardized documentation per IVDD requirements, and expedited notified body reviews, ensuring flawless compliance and rapid market access.

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