On March 1, 2016, the 2016 version of ISO 13485 was released. The new version of the Standard now requires procedures for design transfer, design changes and design and development files in an effort to be harmonized further with US regulatory requirements. Then in February 2, 2024, the FDA released the QMSR–which goes into effect on February 2, 2026. The new QMSR does not include the term Design History File (DHF). Instead, the FDA is incorporating the requirements of ISO 13485 by reference. Specifically, that includes Clause 4.2.3 for Medical Device File. Therefore, this presentation was created to specifically identify changes needed to your design controls procedure in order to comply with ISO 13485:2016 and the QMSR. This webinar will be hosted live on September 26, 2024 @ 10:30 a.m. ET. If you purchased the webinar before September 26, you will receive login information to participate in the live webinar. The webinar will be hosted in Streamyard.com. If you are unable to participate in the live webinar, please send us your questions in advance so that we can be sure to address your questions in the live webinar. You will be able to download the recording from the Dropbox folder after the live webinar and you can watch it as many times as needed. If you are interested in trying Streamyard for developing your own video content, please check out StreamYard: https://streamyard.com/pal/d/4790150438977536