This event explores the evolving regulatory landscape for Software as a Medical Device (SaMD) in 2026, with a focused comparison of FDA expectations and EU MDR requirements. The session highlights practical differences in regulatory strategy, technical documentation, and compliance planning for organizations that develop, validate, or maintain SaMD products across global markets.
Courtyard by Marriott
4884 Main Street
Frisco, TX 75034
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to [email protected]. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email [email protected] with the event title, name of the original registrant and the contact information for the new attendee.
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected].


Leader of the Healthcare & Life Sciences Practice at Cyient, Cyient
Umesh Kuppuraj leads the Healthcare & Life Sciences practice at Cyient, where he shapes strategy, solutioning, and AI-enabled transformation for global MedTech and pharmaceutical clients. With over two decades spanning product engineering, quality systems, and regulatory-aligned lifecycle management, he brings practitioner-level depth to executive-level engagements. Umesh's work sits at the intersection of engineering services and regulatory rigor spanning ISO 13485, ISO 14971, FDA 510(k), and EU MDR compliance frameworks. He has led large-scale lifecycle management programs for MedTech OEMs, with particular focus on post-market sustainability, design change governance, and the operationalization of quality excellence across distributed, multi-geo delivery models. A recognized thought leader on the application of AI and intelligent automation in regulated healthcare environments, Umesh is actively developing next-generation platforms that address compliance gaps, accelerate regulatory submissions, and embed quality at the point of engineering. He advises senior stakeholders on operating model design, regulatory readiness, and the strategic use of emerging technologies within GxP and FDA-regulated contexts. At RAPS, Umesh brings a practitioner's perspective on how MedTech organizations can scale lifecycle services without compromising regulatory integrity and what it takes to build AI-driven capabilities that are both innovation-forward and audit-ready.