Trends in AI-led Productivity Gains in Compliance Management In the Latest Konfer Newsletter

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Konfer Inc.'s General Manager of Healthcare, Ishita Sharan, delivered a compelling presentation at the BIONews & live event on June 3, 2025. Her session, "Operationalizing Medical Device Compliance Efficiently and at Scale with AI and Automation," delved into how AI and automation are revolutionizing the complex and resource-intensive landscape of FDA compliance for medical devices.

The talk explored how these advanced technologies translate regulations like 21 CFR 820, 803, 806, and ISO 13485 into structured control frameworks. Ishita discussed how these frameworks are then validated against extensive evidence, including SOPs, design history files, risk management plans, and quality records. Attendees commended her for sharing how Konfer's Agentic AI significantly reduces costs, shortens submission timelines, and enhances audit readiness, particularly benefiting early-stage and growing medtech companies.

Interested in learning more about FDA compliance management using Konfer's Agentic AI? Please contact us directly to set up a Proof of Concept (POC) tailored to your business needs.

Konfer's Head of India, Trinjan Chatterjee, chaired the keynote session at the International Symposium on Devices, Circuits, and Systems (ISDCS) 2025, organized by IIEST Shibpur and Hiroshima University. During this session, Dr. Prith Banerjee, CTO of Ansys, highlighted how GPUs are being used for implementing Quantum computing Qbits.

Konfer GRC Agents are designed to implement and manage GRC by:

1. Eliminating expensive manual effort for assessments, evidence, and reporting
2. Continuous Compliance with constantly changing and ever-proliferating regulations, amendments, and interpretations
3. Continuous Monitoring and Real-time Risk Visibility across all assets and third-party suppliers

FDA Commissioner Martin A. Makary (source: FDA)

FDA Commissioner Martin A. Makary, M.D., M.P.H., announced the rollout of the Generative AI-based tools across all FDA centers by June 30, 2025, after completing a pilot by FDA scientists and subject-matter experts (SME) of these AI tools that eliminated tedious, repetitive tasks that often slow down the review process. Dr. Makary commented: "I was blown away by the success of our first AI-assisted scientific review pilot. We need to value our scientists' time and reduce the amount of non-productive busywork that has historically consumed much of the review process. The agency-wide deployment of these capabilities holds tremendous promise in accelerating the review time for new therapies,"

Jinzhong (Jin) Liu, Deputy Director, Office of Drug Evaluation Sciences, Office of New Drugs in FDA's Center for Drug Evaluation and Research (CDER), said: "This is a game-changer technology that has enabled me to perform scientific review tasks in minutes that used to take three days."

To reflect the urgency of this effort, FDA Commissioner has directed all FDA centers to begin deployment immediately, with the goal of full integration by the end of June. Work will continue to expand use cases, improve functionality and adapt to the evolving needs of each center after June 30. By that date, all centers will be operating on a common, secure generative AI system integrated with the FDA’s internal data platforms.

Konfer welcomes FDA decision to use AI for accelerating review of new therapies. Konfer offers Agentic AI solutions for its medtech customers to accelerate the FDA compliance process by reducing costs, shortening submission timelines, and enabling teams to become audit-ready at any time, enabling faster time-to-revenue. Konfer's Agentic AI solutions translate FDA regulations like 21 CFR 820, 803, 806, and ISO 13485 into structured control frameworks, and customers then validate them against extensive evidence, including SOPs, design history files, risk management plans, and quality records.

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