Minneapolis, MN – September 30, 2025 — Mind Grove hosted a pivotal webinar on September 24, 2025 featuring “The New Reality: When Regulators Use AI to Review, Smart QA Professionals Use AI to Create,” presented by industry veteran Krystal Santiago and drew strong engagement from MedTech professionals navigating this technological transformation.
Since 2023, AI has been increasingly deployed in regulatory review processes for 510(k) submissions, pattern recognition in clinical data, and automated risk assessments. This evolution creates both opportunity and urgency for quality and regulatory teams to adopt complementary AI capabilities.
“The regulatory landscape is evolving rapidly with AI integration,” said Krystal Santiago, medical device regulatory and quality consultant at Santiago Engineers. “Quality and regulatory professionals who strategically adopt AI tools can dramatically improve efficiency while maintaining the rigorous oversight that ensures patient safety and regulatory compliance.”
From Documentation Overload to Strategic Work
Santiago shared her personal transformation from 55+ hour weeks consumed by documentation to reclaiming time for strategic oversight—a shift achieved in just three months through systematic AI adoption. She outlined a practical toolkit for regulatory and quality professionals: Claude Pro for complex documents and submissions, Perplexity Pro for rapid regulatory research, ChatGPT Plus for brainstorming and graphics, and specialized tools like Nyquist AI for predicate mapping.
The presentation emphasized starting with the biggest time sink, mastering one tool, then systematically expanding capabilities. Santiago demonstrated how structured AI use transformed design requirements from a 1-2 week process into 2 days, and Instructions for Use from days to hours—with compliance-ready content.
A Proven Three-Step Framework
Santiago introduced a prompt engineering system specifically for quality and regulatory documentation: structuring prompts with role, instruction, context, examples, constraints, and output format; running reality checks to refine outputs for regulatory compliance; and building a personal prompt library for consistency.
Critically, she outlined clear boundaries: AI excels at documentation structure, formatting, and drafting but should never handle final strategy calls, CAPA root cause analysis, or client-specific risk assessments. “AI is a multiplier that allows small teams to perform like larger ones,” Santiago noted. “It handles the documentation heavy lifting so professionals can focus on judgment calls that truly require expertise.”
The webinar also addressed risks including AI hallucinations—Santiago demonstrated the importance of fact-checking every output—and usage limits that require session management. She emphasized adjusting AI tool settings to prevent training models on proprietary data.
Industry-Wide Implications
Mind Grove’s webinar series continues addressing skill gaps in an industry where 80% of U.S. medical device companies are small to mid-sized businesses facing acquisition timelines now stretching 8-12 years. Strategic AI adoption offers a path to compress development timelines while maintaining regulatory rigor.
“Krystal’s presentation showed that AI represents a fundamental shift in how we deliver quality outcomes,” said Cindy Grabowski, Founder and Chief Pathfinder at Mind Grove. “For resource-constrained teams, it’s about working smarter—using AI for documentation efficiency while preserving human expertise for strategic oversight.”
Santiago concluded with a clear implementation roadmap: test an AI tool on your biggest time sink this week; build your first 5 prompts this month while tracking ROI; and implement one full workflow this quarter while training team members.
To access resources from the Mind Grove Insights webinar series or explore training programs in Quality Assurance, Regulatory Affairs, Clinical Affairs, Data Management, Reimbursement, and Marketing, visit https://mindgrove.com or follow Mind Grove, Inc. on LinkedIn.
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About the Speaker
Krystal Santiago brings over two decades of leadership in quality assurance, regulatory affairs, and clinical operations within the medical device industry. Having served as Vice President of Quality Assurance and Regulatory Affairs, she has secured multiple FDA product approvals, including Breakthrough Device status, and successfully implemented quality systems across organizations including Edwards Lifesciences, NXT Biomedical, and Reflow Medical. She continues contributing to the industry through her consulting practice, providing strategic regulatory guidance to start-up companies.
About Mind Grove
Founded in 2024 by MedTech veteran Cindy Grabowski, Mind Grove is a women-led eLearning platform dedicated exclusively to the medical device sector. Unlike traditional programs focused on pharmaceutical models, Mind Grove offers structured, skills-based training across six critical disciplines—Clinical Affairs, Regulatory Affairs, Quality Assurance, Reimbursement, Data Management, and Marketing. Learn more at https://mindgrove.com.
For media inquiries:
Cindy Grabowski
Founder & Chief Pathfinder – Mind Grove, Inc.
cgrabowski@mindgrove.com
(480) 298-8600