戻る Agenda
D1.S3: QMS in Medical Device Development: Design & Development, Verification & Validation, and Compliance Requirement in India, US & EU
Session Chair(s)
Rajendran Varadharaj
General Manager Operations
MHS, TUV SUD India, India
Session Overview:This session will provide a comprehensive overview of Quality Management System (QMS) requirements across major regulatory jurisdictions including an emphasis on evolving demands in digital health and AI-enabled medical technologies Focusing on ISO 13485 as the global benchmark, the session will explore region-specific expectations, including India's Medical Devices Rules (2017), the U.S. FDA’s proposed Quality Management System Regulation (QMSR), and the EU MDR’s emphasis on lifecycle-based quality assurance. Key topics include design and development controls, verification and validation (V&V), documentation practices, and risk management. Verification and validation (V&V) ensure that a medical device is designed correctly (verification) and performs safely and effectively for its intended use (validation). This is critical for regulatory approval, patient safety, and product reliability. Attendees will gain actionable insights on aligning QMS strategies to support compliance, product integrity, and timely market access. This session is ideal for regulatory, quality, and R&D professionals seeking to navigate evolving global standards while driving innovation in medical device development.
Speaker(s)
Redefining Quality: FDA’s Alignment with ISO 13485 and Its Impact on Manufacturers
Rupam Chaudhary
L&T, India
Head of MedTech
When Quality is the Key – Quality Management Systems, Conformity Assessment, and Compliance Strategies for Medical Devices
Vareena Raina
Bhat Assurance International (BAI) , India
Advisor/Trainer for Medical device QMS and regulatory requirements
Panel Discussion with Q&A:
Leena Bera
Zenith Quality Assessors Private Limited, India
Chief Executive Officer