In an evolving healthcare landscape, Medical Device Reporting (MDR) Vigilance serves as a cornerstone of patient safety and regulatory compliance. Effective vigilance ensures that adverse events, malfunctions, and potential risks associated with medical devices are identified, analyzed, and mitigated promptly. This session delves into the latest innovations shaping MDR vigilance, including AI-driven automation, real-time data analytics, and predictive risk assessment models that enhance post-market surveillance. We will explore how regulatory bodies are adapting to technological advancements and how medical device companies can leverage machine learning and automation to streamline reporting, reduce errors, and improve response times. Additionally, real-world case studies will highlight the impact of robust MDR vigilance programs, demonstrating how timely detection and corrective actions can prevent serious adverse events and enhance patient outcomes. Attendees will gain insights into emerging trends, regulatory expectations, and best practices to navigate the evolving landscape of medical device safety. By embracing innovative vigilance strategies, companies can move beyond compliance to a proactive, patient-centric approach—ultimately ensuring safer medical devices and improved healthcare outcomes.
Registration Fee: Free
Final year UG students / PG students / Research Scholars from various institutions who are interested in working in the field of AI for Biomedical Applications are encouraged to attend the webinar.
Applicable to candidate holding a B.E/ B.Tech in Electronics and Communication Engineering, Electrical and Electronics Engineering, Electronics and Instrumentation Engineering, Biomedical Engineering, Chemical Engineering, Mechatronics Engineering, Bio-Technology, Artificial Intelligence and allied branches),or equivalent five-year degree in M.Sc. Electronics, M.Sc Physics, M.Sc Chemistry, M.Sc Microbiology, M.Sc Data Science)
Ms. Anushruthi S
Quality & Regulatory
MDR Vigilance Specialist I
Medtronic Engineering and Innovation Center
About the Speaker
Ms. Anushruthi is a passionate medical device professional with a strong focus on MDR vigilance and regulatory compliance at Medtronic. She specializes in medical device safety, post-market surveillance, and proactive vigilance strategies, with a comprehensive understanding of global standards such as EU MDR 2017/745, FDA 21 CFR Part 803, ISO 13485, and ISO 14971. With over two years of experience, she plays a vital role in analyzing adverse events, ensuring regulatory compliance, and contributing to continuous improvement in medical device safety. Her journey in the healthcare technology field is driven by her commitment to enhancing patient safety through rigorous regulatory risk assessments and vigilance processes. Ms. Anushruthi is dedicated to ensuring that innovations in medical devices result in safer outcomes for patients. She stays up to date with emerging trends in the medical device field, including advancements in artificial intelligence for vigilance. Her commitment to learning and staying ahead of regulatory changes allows her to be at the forefront of ensuring safer medical devices for patients.
For more details:
Contact: Dr. J. Aravinth
Ph: +91 9566772677 / 0422-2685734
Email: eceseminars@cb.amrita.edu