Join leaders from across the Medical Device industry as we explore how AI is reshaping medical writing, clinical evaluation reviews, systematic literature reviews, and other components of EU MDR medical writing.
The session brings together senior decision-makers for meaningful conversations on the real financial impact of AI-driven approaches to compliance and documentation.
Through a discussion-led format, we’ll go beyond the buzz to examine how organizations are achieving measurable ROI — including 2–3-year roadmaps to significant cost and time savings, higher-quality submissions with fewer Notified Bodies feedback, and more efficient lifecycle management.
You’ll hear from industry experts and peers who are already realizing the benefits of AI-powered solutions and gain practical insights to help you build your own efficiency roadmap.
Leadership Workshop: ROI strategies for AI applications in EU MDR Medical Writing Maintenance.
RSVP
Discuss challenges and best practices for AI in EU MDR medical writing with leaders from across the industry
See how AI-driven processes are delivering measurable ROI, higher-quality submissions, and more efficient lifecycle management.
Identify strategic opportunities to leverage AI for cost and time savings in your organization.
Walk away with practical ideas to implement AI solutions and improve operational efficiency
| 2:45PM - 3PM | Welcome - Arrive and meet your fellow delegates |
| 3PM | Workshop starts |
| 4PM - 4:30PM | Working Refreshments (Light Bites Served) |
| 5PM | Workshop finishes |
| 5PM - 5:30PM | Networking |
More hosts to be announced soon.
VP Regulatory Affairs and QMS, Circle Cardiovascular Imaging
A strategic leader with over 32 years in the medical device industry, Shirantha specializes in building and overseeing global Regulatory Affairs, Compliance, and Quality Management Systems.
During his 17-year tenure at Circle Cardiovascular Imaging, he has helped guide the company from start-up to a global organization through leadership in regulatory strategy, QMS development, and lifecycle compliance.
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Vice President, Business Development - Medical Device
Erin brings over 20 years of experience in medical device and diagnostics, including leadership roles at Medtronic and GE Healthcare.
She has strong expertise in helping clients leverage technology and services to grow their business by solving regulatory, quality and commercial challenges.
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CHIEF EXECUTIVE OFFICER
With nearly 15 years of industry experience, Sonia envisioned an opportunity to support life sciences companies in bridging the gap between regulatory intelligence and the operational activities associated with compliance. Prior to co-founding Celegence, Sonia Veluchamy was the Managing Director for ArisGlobal, a company that provides technology solutions for close to 200 life science companies worldwide, including top 10 pharmaceutical companies, with the objective of accelerating drug development and ensuring global compliance for its customers. At ArisGlobal, Sonia led the operations for the company and expanded its customer base to 30 of the top 50 global pharmaceutical companies. Sonia received her BA in Economics from the University of Chicago and her MBA in Finance & Entrepreneurship from Columbia Business School.
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Join us in Boston
| Venue | Committee |
| Address | 50 Northern Avenue, Boston, MA, 02210 |
Questions? Contact info@celegence.com