Industry News
The latest medical device regulatory news, clinical trials, and market insights
Insulet Voluntary Correction for Omnipod 5 Pods in the U.S.
Insulet issues a voluntary correction for select Omnipod 5 Pod lots in the U.S. due to a tubing tear risk,…
FDA Webinar: How to Make Efficient FDA-Compliant Clinical Protocol Amendments
A 60-minute FDA training webinar covering protocol modification strategies for regulatory compliance in clinical investigations for medical devices. Register /…
FDA Webinar: Moving Beyond Minimum GMP Compliance – Navigating the FDA QMM Framework
This webinar explores advanced manufacturing quality approaches beyond baseline GMP requirements, focusing on the FDA Quality Management Maturity (QMM) framework…
FDA Webinar: Regulatory Strategies for Small and Medium Medical Device Companies
Tailored compliance pathways and regulatory strategies for smaller medical device organizations navigating FDA requirements. Register / More info
FDA Webinar: Avoid Data Integrity Issues – How to Audit a CRO and Other Vendors
This session covers vendor oversight and records management verification to avoid data integrity issues in medical device development. Register /…
FDA Webinar: New 510(k) for Modified 510(k)-Cleared or Exempt Devices – Best Practices
Best practices for resubmission requirements when modifying previously 510(k)-cleared or exempt medical devices. Register / More info
FDA Webinar: The R2 Revolution – Transforming CMC Summaries into Regulatory Assets
Learn how to optimize Chemistry, Manufacturing, and Controls (CMC) documentation for FDA submissions. Register / More info
FDA REdI Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products
The FDA Regulatory Education for Industry (REdI) Annual Conference provides participants with a strong foundation in FDA regulatory requirements, with…
FDA Webinar: Software Validation for Medical Devices Under QMSR
FDA training session on software validation requirements for medical devices under the new Quality Management System Regulation (QMSR). Register /…
FDA Webinar: Facility Validation and Equipment Qualification for Medical Devices
This webinar covers facility validation and equipment qualification requirements for medical device manufacturing under FDA regulations. Register / More info
FDA Webinar: Expedited Approval Pathways for Medical Devices
Overview of FDA expedited approval pathways including Breakthrough Device Designation, De Novo classification, and Pre-Submission strategies for medical devices. Register…
EUDAMED Mandatory Registration Webinar – What MedTech Companies Need to Know
With EUDAMED becoming mandatory on May 28, 2026, this webinar covers the key deadlines and requirements for actor, device, and…