Author name: Dr. Hatem Rabeh

Tailored compliance pathways and regulatory strategies for smaller medical device organizations navigating FDA requirements. Register / More info

This session covers vendor oversight and records management verification to avoid data integrity issues in medical device development. Register /

Best practices for resubmission requirements when modifying previously 510(k)-cleared or exempt medical devices. Register / More info

Learn how to optimize Chemistry, Manufacturing, and Controls (CMC) documentation for FDA submissions. Register / More info

The FDA Regulatory Education for Industry (REdI) Annual Conference provides participants with a strong foundation in FDA regulatory requirements, with

FDA training session on software validation requirements for medical devices under the new Quality Management System Regulation (QMSR). Register /

This webinar covers facility validation and equipment qualification requirements for medical device manufacturing under FDA regulations. Register / More info

Overview of FDA expedited approval pathways including Breakthrough Device Designation, De Novo classification, and Pre-Submission strategies for medical devices. Register

With EUDAMED becoming mandatory on May 28, 2026, this webinar covers the key deadlines and requirements for actor, device, and

Training on the transition to eCTD 4.0 electronic submission standard for medical device regulatory filings with the FDA. Register /