Indegene accelerated remediation of a UK-based medical devices company's Quality Management System (QMS), ensuring 100% compliance across EN ISO 9001:2015, EN ISO 13485:2016, 21 CFR Part 820 QSR, MDSAP, and EU MDR requirements while drafting, reviewing, and delivering 155+ documents in 12 weeks with 90% first-draft acceptance. Challenges included gaps in EU MDR processes, outdated documents misaligned with current operations, and maintaining a unified compliant QMS. Indegene's advanced software automated gap analysis, standardized documentation workflows, and enforced real-time compliance checks, bridging deficiencies swiftly and upholding quality, timelines, and global standards for radiation therapy solutions.

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