Date: 27 March 2025
Time: 17:00h - 18:00h CET / 11:00 am - 12:00 pm EST
Location: Virtual
Language: English
Introduction
Join Qserve and TransPerfect for a live webinar on March 27th at 5:00 pm CET/11:00 am EST, where we will unveil the results of our industry survey on the role of Artificial Intelligence (AI) in clinical and regulatory content. This session will explore how AI is being evaluated and applied to search, analyze, and generate clinical and regulatory content, offering valuable insights into emerging trends, key challenges, and future opportunities.
AI is increasingly being utilized in medical device products… but what about medical device processes? AI chipmaker NVIDIA estimates there are 90% more applications for AI in device production processes than products themselves. But where, exactly, is the industry at with regard to process AI implementation? Our panel of experts will break down survey findings and provide insights to help professionals understand opportunities and challenges for AI-driven processes for regulatory and clinical applications.
The webinar consists of a 45-minute presentation and a live Q&A. Questions for the Q&A session can be sent in through the registration form, by email at marketing@qservegroup.com, or during the webinar.
Learning Objectives
- Gain insights into how AI is currently used for clinical and regulatory content management.
- Understand current opportunities and challenges as identified by industry practitioners.
Who should attend the webinar?
- Regulatory Affairs and Quality Assurance professionals
- Clinical and Medical Writing experts
- Labeling and Documentation Managers
- Medical Device Manufacturers and Developers
- AI and Digital Health specialists
- Professionals involved in Compliance, Risk Management, and Post-Market Surveillance
About the Hosts
Bianca Lutters, Head of Clinical Operations at Qserve. Bianca has over 15 years of experience in the medical device field, including ten years at DEKRA and BSI as a Notified Body expert, assessing technical files and conducting QMS audits. She specializes in EU and US regulatory strategy, clinical evaluations, quality management, and interactions with regulatory authorities. With a background in medical biology and a PhD in biochemistry, she has also led regulatory and quality functions in a startup developing high-risk biodegradable cardiovascular devices.
Marc Miller, President TransPerfect Medical Device Solutions. Marc has over thirty years assisting all sizes of medical device manufacturers with translation and process automation for Labeling, Marketing, e-Learning, Software, and other product-related content. He founded the first translation company certified to ISO 13485 and ISO 14971, co-authored the industry's only risk management patent, and developed the first content automation system specifically designed to meet MDR and IVDR content requirements. Marc holds a BA in Language and Literature from Harvard University and MBA from Stirling University (Scotland).