AI software assessment checklist for medical devices

Complimentary Webinar on AI in Medical Devices: Applicable Guidance to Prepare for MDR Conformity Assessment

Artificial Intelligence (AI) is revolutionizing the healthcare and medical device industries by enhancing clinical decision-making, diagnostics, and patient care. However, its integration into medical devices presents unique challenges in terms of safety, transparency, and regulatory compliance.

Join our upcoming webinar to gain valuable insights into how you can assess AI software used in medical devices effectively. Learn how to apply a structured evaluation checklist that ensures alignment with global regulatory expectations and mitigates risks throughout the AI software lifecycle.

Importance of topic:

With increasing scrutiny from regulatory bodies such as the FDA, EU MDR, and others worldwide, it's critical for medical device professionals to understand how to validate and manage AI technologies in compliance with applicable standards. This webinar empowers stakeholders with practical tools and expert insights to:

  • Navigate evolving regulatory landscapes
  • Minimize compliance risks
  • Build safer and more reliable AI-based medical solutions

Schedule on:

Date and time: 19th June 2025 | 3.00pm - 4.00pm IST

Speaker: Trisha Punj

Language: English | Online

Agenda

  • Overview of regulatory expectations for AI-based medical devices
  • Key elements of an AI software assessment checklist
  • Aligning the AI software lifecycle with international standards
  • Common pitfalls in AI software validation and how to avoid them

Who should attend

  • Quality Assurance Professionals
  • Medical Device Manufacturers and Developers
  • Clinical Evaluation and Risk Management Teams
  • R&D and AI/ML Engineers in Healthcare
  • Compliance Officers and Product Managers in MedTech

MEET THE SPEAKER:

Trisha Punj

Trisha Punj is a Principal Engineer, AI Software Assessor at TÜV SÜD, bringing over 10 years of experience in artificial intelligence and software development. Her expertise lies in assessing AI-enabled medical technologies for compliance with the EU Medical Device Regulation (MDR), with a focus on Software as a Medical Device (SaMD).

Trisha specializes in AI risk management, quality management, ethics, and regulatory frameworks. She is deeply involved in evaluating the safety, performance, and security of AI systems in healthcare, ensuring they meet stringent international standards.