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Newsletter V. 2024 Issue 2

Embracing Change

Embracing Change: Managing Medical Devices That Are Never Finished

Online webinar – July 25

Join us for a lively discussion by Aaron Joseph of how to tackle the challenges of managing software-intensive, connected medical devices; products that we want to grow and evolve after initial launch. Bring your questions on how to set up a product life cycle and tailor quality system procedures to efficiently manage post-market changes of all types.


PCCP Recorded Webinar

Pre-determined Change Control Plan (PCCP)
This is a valuable new tool provided by the FDA to enable more flexibility in managing product changes after initial product approval. The PCCP is submitted with the initial product design to the FDA and it then enables future product changes, within the limits of the PCCP, without triggering re-submissions.

Accelerate Updates to AI Algorithms with PCCP: recorded webinar (June 28, 2024) sponsored by Orthogonal; panel members discuss general considerations for leveraging a PCCP and particular usage with AI/ML enabled medical devices.

FDA’s Latest Pre-Submission Guidance and Uncovering PCCP Best Practices: recorded webinar (June 29, 2023) sponsored by RQM+; panel members discuss regulatory strategy for pre-submission meetings with FDA and tips for writing PCCPs (requires contact information to download).


Upcoming Events

Sept 5 TRUE QUALITY ROADSHOW in Austin TX – free event series hosted by Greenlight Guru
https://www.greenlight.guru/true-quality-roadshow

Sept 16-20  LSI EMERGING MEDTECH SUMMIT EUROPE 2024 in  Portugal
https://www.lsieuropesummit.com/

Sept 25-26 BIOMEDevice Boston
https://www.medeviceboston.com/en/home.html

Oct 3 TRUE QUALITY ROADSHOW in Salt Lake City UT –  free event series hosted by Greenlight Guru 
https://www.greenlight.guru/true-quality-roadshow

Nov 20-21 BIOMEDevice Silicon Valley
https://www.medevicesiliconvalley.com/en/home.html

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