Webinar – Standards, Standards, Standards – Makes the Medical Device World go Around

leoeisner — Wed, 24 Oct 2018 20:53:21 +0000

Standards are a key priority for the International Medical Device Regulators Forum (IMDRF).

Its forthcoming guidance, “Optimizing Standards for Regulatory Use,” encourages the development of ‘regulatory ready’ standards, including direction to Standards Development Organizations (SDOs) to consider medical device ‘essential principles’ when writing standards.

This webinar will introduce viewers to IMDRF, review this upcoming guidance, and discuss the role IMDRF and its priorities play in relation to international medical electrical equipment standards in the IEC 60601 series (IEC 60601-X-YY / IEC/ISO 80601-2-YY), proposed IEC 60601 series updates, and significant changes planned for the draft IEC 60601-1 Ed3.2.

Finally, it will summarize why standards conformity assessment is critical to ensure success of global harmonization.

This webinar is being co-presented by me, Leo Eisner, the “IEC 60601 Guy”, founder and principal regulatory & product safety consultant at Eisner Safety Consultants, along with Captain Scott Colburn and Gail Rodriguez of the FDA, and moderated by Jon Speer of Greenlight Guru.

WHEN: November 1, 2018 1PM ET/10AM PT

Sign-up now for the limited live seating of the free webinar

Top Take Aways

Overview of IMDRF
IMDRF’s forthcoming guidance “Optimizing Standards for Regulatory Use”
Key concept of the Essential Principles of Safety & Performance
Concept of Essential Performance in IEC 60601 standards for medical electrical equipment and how it relates to the Essential Principles
Upcoming major changes and revisions to the IEC 60601 series

Who Should Attend?

Medical Device Industry Executives
Regulatory Affairs Professionals and Management
Quality Professionals and Management
Clinical Affairs Professionals and Management
R&D Engineers and Management
Regulators
Standards Development Organizations and Standards Developers
Test Labs
Accreditors

IMDRF History & Further Details About Webinar

The International Medical Device Regulators Forum (IMDRF) was established in February 2011 as a forum for a voluntary group of medical device regulators from around the world to promote medical device regulatory harmonization. Standards, as an important resource for harmonization, are a key priority for IMDRF. The draft IMDRF guidance “Optimizing Standards for Regulatory Use” is primarily directed at regulatory authorities (RAs), Standards Development Organizations (SDOs) and those interested in the application of standards to support regulatory frameworks (i.e. manufacturers), the guidance aims to encourage the development of ‘regulatory ready’ standards, including direction to SDOs to consider medical device ‘essential principles’ when writing standards. Essential principles, which are outlined in ISO 16142 and currently under development at IMDRF, will include references to medical device performance.

The IEC 60601 series of standards for medical electrical equipment and systems also feature expectations for essential performance. We will highlight the intersection of the two key concepts between the essential principles and the IEC essential performance to demonstrate how standards can help with global harmonization in medical device regulation.

Further, we will provide a brief update on the latest standards revision status for the IEC 60601 series, including some significant changes planned for the draft IEC 60601-1 Ed3.2.

About Leo Eisner

Leo is heavily involved in the IEC 60601 standards development process for several of the standards in the series. He is the US Co-chair for IEC SC62D in charge of a majority of the IEC 60601-2-XX / IEC/ISO 80601-2-XX Particular Standards. He is on several Working Groups and Maintenance Teams working on the development of the draft IEC 60601-1, edition 3.2 (3rd edition + Amendment 2).

Eisner Safety Consultants has helped countless clients thru the Regulatory and Product Safety maze over our 22 year history of the company. Leo has over 30 years experience in product safety and 24 years experience in the medical device industry. Leo ran the Compliance Engineering Group at Karl Storz and was a Senior Product Safety engineer at TÜV Product Service prior to starting Eisner Safety Consultants. Leo has worked as a Notified Body auditor and technical reviewer for TÜV Product Service/SÜD, NSAI, and is currently a technical reviewer for Pre-Safe (Joint venture between NEMKO & DNV).

About greenlight guru

greenlight.guru is the only Quality Management Software built exclusively for the unique needs of medical device companies, allowing you to bring safer devices to market faster while reducing risk and ensuring compliance. Visit their home page to learn more.

About Eisner Safety Consultants

ABOUT FDA CDRH
In keeping with our mission, the Center for Devices and Radiological Health (CDRH) is responsible for protecting and promoting the public health. We assure that patients and have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. We provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.

We seek to continually improve our effectiveness in fulfilling our mission by planning strategically and regularly monitoring our progress.

Oct 2018 – Eisner Safety Consultants