Thank you so much for joining our recent webinar on AI technology for regulatory intelligence and surveillance, and for submitting such insightful questions! If you missed it, you can find the link at the end of this post. We received an overwhelming number of inquiries during the Q&A that truly deserve thorough answers.
Because of the depth and importance of these questions, we’ve decided to split them into two parts. Here’s the first part of the Q&A, addressing some key topics about AI’s role in regulatory affairs.
Where Can AI Be Most Beneficial in Medical Device Quality, and What are Some Examples?
AI has the potential to streamline and improve regulatory practices in medical device quality. Here are some key ways AI can be applied:
Identifying Similar Devices: AI can compare new devices with existing ones to ensure they meet quality and performance standards.
Market Data Analysis: AI can analyze market trends and data to help companies make informed decisions.
State of the Art: AI can keep companies updated on the latest technological advancements and best practices.
Compliance Gaps in Documentation: AI can review documents to identify and suggest improvements in compliance.
Formulation of Text: AI can help in drafting clear, concise, and compliant documentation.
Workflow Optimization: AI can streamline processes to improve efficiency while maintaining high quality.
What are the Future Trends in AI for Regulatory Surveillance, and What are the Strategies for Preparing for Them?
As AI technology continues to evolve, its impact on regulatory affairs will grow significantly. Here are some emerging trends and strategies for preparation:
Implementing an AI Policy: Establish clear guidelines on how AI will be used within the organization. Be mindful of your company’s information management security policies before uploading any documents to AI services.
While AI services like ChatGPT and Gemini typically do not store uploaded content permanently, there can be temporary storage in online caches or session data. This can be considered equivalent to storing information privately or on private cloud storage, or at home! Quality Management System (QMS) documents, in particular, are sensitive as they contain proprietary processes and procedures.
Using Corporate AI Accounts: Ensure AI tools are accessed through corporate accounts for security and accountability.
Declaration of AI Use: Transparency in documents by declaring AI assistance.
“AI was used to assist in the formulation of text in this document for better understanding.”
“AI was used to compare devices and identify similar devices before final sorting by the author.”
Regulatory Change Alerts: AI can alert regulatory professionals of pending regulatory changes that may impact their products.
Multilingual Document Understanding: AI can help regulatory professionals better interpret international regulatory documents in different languages.
Connecting Multiple Regulations: AI can help regulatory professionals connect the dots between multiple regulations, such as MDR, Radio Telecommunications, and Materials.
What are the Recommended Large Language Models (LLMs) for Regulatory Applications?
Several large language models (LLMs) can be used in regulatory applications, providing support for tasks like data analysis, document generation, and regulatory compliance. Some recommended LLMs include:
Google-Gemini
Google-ELECTRA
Google-BERT
Claude
Additionally, several JavaScript-based models can be applied:
WebLLM
EmbedJS
LLM.js
Transcend
What are the Key Principles of Good AI Practice?
When integrating AI into regulatory affairs, it’s essential to follow best practices to ensure the effectiveness, security, and accountability of AI use. Key principles include:
Data Integrity & Accuracy
Verify and validate AI-generated content.
Ensure human review and approval.
Ethical and Responsible Use
Mitigate biases in AI-generated documents.
Provide transparency and context for AI content.
Risk Management & Compliance
Ensure compliance with industry regulations (FDA, ISO).
Conduct regular audits of AI-generated documents.
Security & Privacy
Protect sensitive data with encryption and access controls.
Ensure AI tools comply with privacy regulations (GDPR, HIPAA).
Continuous Improvement & Learning
Gather user feedback for content improvement.
Provide training on AI tools and best practices.
Governance & Accountability
Establish governance frameworks for AI use.
Define roles and responsibilities for document creation.
Embrace AI and learn how you can best use it in your daily tasks. AI is a powerful assistant but requires human verification. AI does not remove the responsibility and accountability of the User/Author of the results.
We hope this Q&A series provides valuable insights into how AI is transforming regulatory affairs. Stay tuned for Part 2, where we will continue exploring more advanced topics related to AI technology in regulatory intelligence and surveillance.
If you haven’t registered yet for Part 2: The Workshop, where we’ll dive deeper into the practical applications and advanced strategies of AI for regulatory intelligence and surveillance—don’t miss out! Spots are limited for these sessions, so we encourage you to register early to secure your place.
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