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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*) was published on 20 Oct 2023 with updated timelines for each module and mandatory use dates for the MDR & IVDR.
The European Commission published two Implementing Decisions: EU 2022/6 and (EU) 2022/15 for the MDR (EU) 2017/745 and IVDR (EU) 2017/746on 5 January 2022 and 7 January 2022 amending Implementing Decision (EU) 2021/1182 and (EU) 2021/1195 all above references are
We did a really popular webinar titled ATTENTION ⚠️ ISO 15223-1 4th Edition is Almost Here: How to Update Your Medical Device Labeling to Comply with the New Requirements and from that webinar came a lot of questions. So, we
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.