3-day Virtual Seminar

AI for Medical Device Documentation

Overview

This webinar looks at generative AI as a documentation-support tool within medical device organisations. It explores useful applications such as structuring working drafts, summarising appropriate information, improving clarity, extracting key points and assisting with comparison or review activities.

The session also examines the questions that should surround those uses. Where did the information come from? Has the output been checked against the source? Is the content suitable for the AI tool being used? Does the activity sit within an established quality or document-control process? Who remains responsible for the final result?

By combining AI productivity concepts with quality and compliance awareness, the webinar gives attendees a framework for using AI more thoughtfully around medical device documentation. Examples are explained within the presentation and do not require participants or the speaker to access external software during the session.

Why you should Attend

AI can produce polished documentation quickly, but polished does not necessarily mean correct, complete or suitable for a regulated medical device environment. Unverified content, missing context, inconsistent terminology or inappropriate handling of sensitive information can turn an efficiency tool into a quality or compliance concern.

This session helps attendees approach AI-assisted documentation with greater control. It explores where generative AI may be useful, what should always be checked, and how teams can preserve the human review, traceability and quality discipline expected around medical device documentation.

Areas Covered in the Session

• Identify documentation activities where generative AI may provide useful support across medical device organisations
  
• Explore uses including structuring working drafts, summarising suitable information, extracting key points and improving clarity
  
• Understand how AI can assist with text comparison, consistency checks and organising information for subsequent professional review
  
• Use better prompts to specify source material, purpose, audience, boundaries and required output more clearly
  
• Recognise hallucinations, omissions and other AI-generated errors that may be difficult to detect in professional-looking documentation
  
• Apply source verification and human review before AI-assisted content is relied upon, approved or incorporated into controlled work
  
• Consider confidentiality, proprietary information and data-handling restrictions when selecting material for use with AI tools
  
• Understand how document control, traceability, quality-system requirements and organisational procedures affect the use of AI-generated content
  
• Create sensible boundaries between lower-risk documentation support and activities requiring formal processes, specialist expertise or greater oversight
  

Who Will Benefit

• Medical Device Regulatory Affairs Professionals
  
• Quality Assurance and Quality Systems Professionals
  
• Document Control and Records Management Teams
  
• Design and Development Professionals
  
• Regulatory Operations and Submission Teams
  
• Clinical and Post-Market Documentation Professionals
  
• Medical and Technical Writers
  
• Supplier Quality and Operations Professionals
  
• Managers responsible for AI adoption within medical device organisations