Mark Richards

How Large Portfolios Can Stay Audit-Ready with Correct, Continuous, and Consistent CER Maintenance

AI and Automation in Clinical Evaluation Reports (CERs): From Burden to Breakthrough

CMC Technical Writing: Strengthening Change Control and Lifecycle Management

EUDAMED Becomes Fully Mandatory from 28 May 2026: What Medical Device & IVD Manufacturers Need to Know

CMC Technical Writing: A Critical Enabler During Product Development

AI in Medical and Technical Writing: Moving Beyond the Hype to Real-World Impact

What is a Service+Tech Model? – The Fastest Path to Integrating AI into Regulatory Operations

From Spreadsheets to Strategic Assets: Key Takeaways from Our Regulatory Data Management Webinar