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Webinar: AI in MedTech RA

Understanding AI Technologies, Regulatory Expectations & Practical Applications

From generative AI chatbots to autonomous agents and specialized regulatory solutions, organizations are exploring how these technologies can support regulatory activities. At the same time, regulators, health authorities, and industry stakeholders are developing their views on AI governance, oversight, and implementation within regulated environments.

This webinar brings together technology experts, regulatory specialists, and industry professionals to explore the current AI landscape, discuss regulatory considerations, and share practical experiences from organizations working with AI today.

Meet the speakers

1. Understanding the AI Landscape

The webinar opens with an overview of the AI technologies currently shaping Regulatory Affairs. We’ll explore the differences between generative AI chatbots, AI agents, and specialized regulatory AI solutions, including how they work, where they can create value, and what organizations should consider when evaluating them.

2. Regulatory Perspectives on AI

As AI adoption accelerates, regulatory expectations are evolving alongside it. This pannel discussion explores current discussions among regulators and health authorities, the impact of developments such as the EU AI Act, and key considerations for organizations operating within regulated environments.

3. Practical Applications and Experiences

The webinar concludes with a panel discussion featuring industry experts who will share perspectives on AI adoption in practice. The discussion will cover real-world applications, lessons learned, implementation challenges, and opportunities for Regulatory Affairs teams looking to make effective use of AI technologies.

Our speakers will also discuss how organizations identify high-value use cases, adapt existing workflows, and determine the appropriate role of human review in AI-assisted processes. The conversation will explore practical approaches to oversight, review checkpoints, and quality control for making effective use of advanced AI agents.

Audience Q&A

You will have the opportunity to engage directly with the speakers and discuss questions relevant to their own organizations and regulatory challenges. Whether your organization is actively exploring AI or still evaluating where it fits, this session is designed to give regulatory professionals a clearer view of the challenges, expectations, and practical realities shaping AI adoption across MedTech.

Robert van Boxtel

Principal Consultant – MDProject

  • A regulatory leader with over 30 years of experience in the medical device industry, featuring a diverse background in design, production, and Notified Body operations (KEMA Quality/Dekra) across the EU and the USA. As a recognized community leader, he also serves as the Chair of the RAPS European Council.

  • Principal Consultant and management team member at Medical Device Project B.V. , where he has spent over 15 years delivering specialized QA and RA consultancy focused on the EU and US markets. His current focus includes supporting innovators with regulatory strategies and providing expert training on the EU MDR, ISO 13485, and risk management to the industry, Notified Bodies, and Competent Authorities.

Gayathri Bhattathiri

Quality & Compliance Officer – Clear.bio

  • Versatile Life Sciences professional with a background in consulting, bringing deep expertise across pharmaceutical, medtech, and regulatory compliance settings.
  • As Compliance & Quality Officer at Clear.bio, she currently leads the MDR Class IIa certification project, applying data-driven decision-making and quality systems to support rapid growth.

Jan Bart Hak

Director Medical Devices Europe – ProPharma

  • Medtech executive with 3 decades of leadership across Regulatory & Clinical Affairs and Quality Compliance.
  • Currently Director Medical Devices Europe at ProPharma, responsible for European operations and accelerating compliant device commercialization.

Ronald Boumans

Owner – Boumans Regulatory Consulting B.V.

  • Elected Medtech Leading Voice in 2025 and 2026, and veteran regulatory expert known for making complex EU compliance topics practical and actionable. 40 years of experience working in industry, competent authority, research, standardization and high-end regulatory consulting.
  • Supports companies as a consultant and PRRC coach, helping them avoid regulatory storms and navigate high‑profile vigilance cases at Boumans Regulatory Consulting and Munich Medtech Consulting.