Event Information

Event Topic:
BIONews & live – Operationalizing Medical Device Compliance Efficiently and at Scale with AI and Automation

Event Description:
FDA compliance for medical devices is complex and resource-heavy, relying on manual interpretation and exhaustive documentation review. This session explores how AI and automation are transforming compliance by translating regulations (21 CFR 820, 803, 806, ISO 13485) into structured control frameworks and validating them against large-scale evidence such as SOPs, design history files, risk management plans, and quality records. We’ll discuss how these platforms reduce costs, shorten submission timelines, and improve audit readiness - especially for early-stage and growing medtech companies.

Date/Time:
Date(s) - 06/03/25
8:15 am - 10:15 am

Event Location:
Zoom talk: https://us02web.zoom.us/j/89077658197:

Speaker Information

Event Speaker:
Ishita Sharan

Event Speaker Title:
General Manager of Healthcare

Event Speaker Company:
Konfer Inc.

Event Speaker Bio:

Ishita is General Manager of Healthcare at Konfer, a technology platform that leverages AI to operationalize regulatory compliance for healthcare organizations. With over 25 years in the technology industry, she has held leadership roles at Cisco, Ericsson, Brocade, and several startups. At Konfer, Ishita focuses on applying the platform's capabilities to healthcare use cases, enabling organizations to navigate complex regulatory environments with efficiency, accuracy, and continuity. Previously, she led a GenAI-based knowledge management initiative at a major hospital with Damo and managed advanced analytics platforms at TCG Digital. Ishita is passionate about enhancing trust, safety, and accountability in healthcare. She holds an MBA from the University of Chicago Booth School of Business, an MS in Computer Engineering from USC, and a B.Tech in E&ECE from the Indian Institute of Technology, Kharagpur.

Event Details

Cost:
$0

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