Mastering DHF, DMR & DHR Training Course: Essential FDA Documentation for Medical Devices (ONLINE EVENT)

A significant market opportunity lies in providing comprehensive training on technical documentation for medical device manufacturing, focusing on DHF, DMR, and DHR. This ensures regulatory compliance ...
Royal Society of Chemistry

Webinar on Conformance of Design History Files for Mature Medical Devices

This webinar on Design History Files (DHF) will provide a step-by-step procedure for all medical device companies that are in need of bring their product design history files up to date with the ...
JD Supra

FDA Finalizes Its Premarket Submissions Guidance for Medical Device Software Functions

On June 14, 2023, FDA finalized its “Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff” (the “2023 Final Guidance”). The ...
MD&M East

A Complete Guide to Medical Device Design and Development

Medical device design and development is a process that helps to ensure devices that go to market are safe, effective, marketable, and profitable. The process is a blueprint of the phases needed to ...