New FDA Guidance on 510(k) Transfer for Medical Devices
A New FDA 510(k) transfer draft outlines key steps for medical device companies.
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Updated Guidance on the FDA Q-Submission (Q-Sub) Program
Discover the latest FDA Q-Submission Guidance to improve medical device submissions, gain early feedback, and streamline your FDA regulatory strategy.
COFEPRIS Warehousing Compliance for Medical Devices
Learn about COFEPRIS warehouse requirements in Mexico for medical devices and IVDs, covering licensing, storage, and distribution compliance.
Tips for Manufacturers Preparing for an FDA PMA Submission
Discover practical tips and key strategies to improve your FDA PMA submission.
IVDR Transition Deadline What Happens After May 26, 2025
Prepare for the IVDR Transition Deadline on May 26, 2025. Learn what legacy IVD manufacturers must do to maintain EU market access.
New Form for Reporting Serious Incidents Now Also Applicable to Switzerland
Learn about the updated Manufacturer Incident Report (MIR) requirements for reporting medical device incidents in Switzerland.
New EU MedTech Regulatory Reform for Medical Technologies
EU MedTech considers regulatory reform changes to maintain Europe's status as a global leader in medical technologies.
Economic Operators Under the MDR and IVDR
This webinar breaks down the roles and responsibilities of economic operators under the MDR and IVDR.
MDR QMS Notified Body Assessment
Webinar: MDR QMS Notified Body Assessment
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