Attention ⚠️ ISO 15223-1 4th Edition is almost here: How to update your medical device labeling to comply with the new 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.

Understanding the new requirements of ISO 15223-1 4th Edition and the intent behind these major changes will be a critically urgent task for both medical device manufacturers and organizations operating within the medical device supply chain.

This free, in-depth webinar will be presented by one of the industry’s most knowledgeable experts on this topic, Leo Eisner, a committee member of ISO/TC 210/WG 3 (ISO 15223-1). Attendees will learn about the latest updates to this key international standard, understand the full scope of changes to the ISO 15223-1 4th Edition, and uncover actionable ways to easily and effectively transition to compliance with the new requirements.

UPDATE: the 4th edition of ISO 15223-1 was published on 6 July 2021 and can be accessed by clicking here.

Watch the webinar

L.Eisner webinar 7-8-21
Specifically, this webinar will cover:
  • Summary of what’s changing from the 3rd to 4th Edition of ISO 15223-1
  • Details about revisions to scope and introduction
  • Explanation of defined terms that have been added and removed from amended version
  • New symbols included in the 4th Edition
  • Overview of the expansion of informative annex containing examples
  • Q&A session
Who Should Attend?
  • Design and Development Engineers and Management
  • Regulatory Affairs Professionals and Management
  • Quality Professionals and Management
  • Medical Device Labeling, Packaging, and Distribution Firms
  • Clinical Affairs Professionals and Management
  • Medical Device Executives
Register Now  

Hosted by

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Presenter: Leonard Eisner

Principal Consultant, Eisner Safety Consultants

Moderator: Etienne Nichols

Medical Device Guru & Community Manager, Greenlight Guru


About Eisner Safety Consultants

Eisner Safety Consultants supports your regulatory, quality systems, product safety,
EMC, and engineering needs. Our experts speed your way to on-time product approvals via safety and regulatory agencies. We provide assistance with U.S., Canadian, European, & other international regulations.
You can see a full list of the service offerings from Eisner Safety Consultants by visiting their website to learn more.


About Greenlight Guru

Greenlight Guru is the only Medical Device Success Platform (MDSP) for companies to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based software, Greenlight Guru is easier to implement, easier to use and designed to fit all medical device needs to enable innovative, safe and effective, True Quality medical devices. Visit our homepage to learn more.

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