The EUDAMED Imperative: Transforming Legacy to Modern with a Data-First Approach

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The EUDAMED Imperative: Transforming Legacy to Modern with a Data-First Approach

EUDAMED represents a seismic shift for the medical device industry, transforming regulatory compliance from a fragmented, document-centric task into a unified, data-driven mandate.

For most companies, achieving full EUDAMED integration isn’t just about submitting data; it’s about fundamentally overhauling decades of legacy processes and systems.

The real challenge lies in this transformation, moving from disparate data silos and manual workflows to a centralized, automated, and governed data ecosystem. A reactive, “compliance-only” approach will lead to immense administrative burden, but a proactive, “data-first” strategy will turn EUDAMED into a powerful enabler of operational efficiency, enhance patient safety, and strategic advantage.

Read more in our latest point of view here: EUDAMED Imperative- Transforming Legacy to Modern with Data First-Approach

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Author Details

Dr. Garima Saroj

Garima brings 8 years of cross-functional experience in healthcare, pharmaceutical consulting, and digital transformation. She has successfully led projects to optimize workflows, implement technology-driven solutions, and enable better decision making through advanced analytics. With experience spanning business analysis, project management and strategy, she is passionate about applying structured yet practical approaches to solve complex regulatory and operational challenges.

Sapna Bhardwaj

Sapna is a seasoned life sciences consultant with over nine years of experience in R&D, Project and Quality Management, Data Analysis, and Computer System Validation (CSV). She has successfully led projects in safety and quality, driving continuous process improvements to enhance client performance. Passionate about innovation, she is eager to explore AI technologies and their responsible application in the life sciences industry.

Eshan Mishra

Eshan is a seasoned pharmaceutical and healthcare consultant with seven years of progressive experience across research, operations, supply chain, and commercial strategy. He has successfully led multiple clinical and commercial process improvement and corporate strategy initiatives, helping global life sciences clients optimize performance and drive efficiency across the value chain. With a strong foundation in pharma strategy consulting and a passion for innovation, Eshan is keenly focused on leveraging data-driven insights and emerging technologies to solve complex business/industry challenges.

Sneham Sen

Sneham is a seasoned Business Analyst with over 6 years of experience in the commercial life sciences domain, specializing in sales, analytics, customer engagement, and data-driven reporting. He has successfully led initiatives in data consolidation, reporting automation, and business process optimization using tools like Power BI. Leveraging his cross-functional expertise, Sneham is passionate about bridging the gap between business needs and data-driven solutions.

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