Standards: Explosion and Challenges Maintaining/Updating

Standards: Explosion and Challenges Maintaining/Updating

Standards: Explosion and Challenges Maintaining/Updating

 My conversation with Subhi Saadeh of Combinate Podcast was very intriguing and he does a fun podcast. Check out the Combinate podcast #132 as I, Leo Eisner, talk about Standards.

Draft EUDAMED Roadmap of Modules

Draft EUDAMED Roadmap Modules

Draft EUDAMED roadmap (of modules*) was published on 20 Oct 2023 with updated timelines for each module and mandatory use dates for the MDR & IVDR.

ATTENTION ⚠️ ISO 15223-1 4TH EDITION IS ALMOST HERE: HOW TO UPDATE YOUR MEDICAL DEVICE LABELING TO COMPLY WITH NEW THE REQUIREMENTS

ATTENTION ⚠️ ISO 15223-1 4TH EDITION IS ALMOST HERE: HOW TO UPDATE YOUR MEDICAL DEVICE LABELING TO COMPLY WITH NEW THE REQUIREMENTS

The international standard for the application of medical device symbols on labels, ISO 15223-1, has been amended and the 4th Edition will replace ISO 15223-1:2016

This amendment is multifaceted and will introduce many new changes to the symbol requirements that medical device organizations around the world will be expected to follow.

The 4th Edition of ISO 15223-1 will include 25 additional symbols in total, newly defined terms and removal of existing terms as well as inclusion of terms from other standards, and expansion of the informative annex containing examples—just to name a few.