QMSR, AI Reviewers and the Value of a Good FDA and Internal Audit
Update: 2025-06-27
Description
In this episode Michelle and Adam Foresman from Ryden Solutions do a deep dive into right-sizing quality systems, lean regulatory practices, and the evolving landscape of AI-driven compliance tools in medtech. They reflect on personal pain points that sparked their ventures, swap audit war stories, and share insights into regulatory shifts like QMSR, MDR, and de-harmonization trends.
Highlights:
- The hidden costs of over-documentation and duplicated audits
- How AI can proactively identify compliance gaps — even across languages
- The future of audits: less paper, more floor time, and higher impact
- Why global harmonization is unraveling, and what that means for QA/RA teams
- Real examples of FDA using AI to detect duplicated or fraudulent data
This episode is a must-listen for quality, regulatory, and compliance leaders, especially those working in startups, scaling medtech companies, and global manufacturers navigating complex, multi-jurisdictional requirements.
Highlights:
- The hidden costs of over-documentation and duplicated audits
- How AI can proactively identify compliance gaps — even across languages
- The future of audits: less paper, more floor time, and higher impact
- Why global harmonization is unraveling, and what that means for QA/RA teams
- Real examples of FDA using AI to detect duplicated or fraudulent data
This episode is a must-listen for quality, regulatory, and compliance leaders, especially those working in startups, scaling medtech companies, and global manufacturers navigating complex, multi-jurisdictional requirements.
Comments
In Channel
Download from Google Play
Download from App Store
United States00:00
00:00
1.0x
