Standards – Makes the Medical Device World go Around

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 IEC 60601-1 series, 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.

SPECIFICALLY This Webinar will Cover:

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

Presenters

leo-eisner-round

Leo Eisner
Principal Consultant
Eisner Safety Consultants

scott-colburn-round

Scott Colburn
Director, CDRH Standards Program
FDA

gail rodriguez-circle

Gail Rodriguez
Senior Policy Advisor, CDRH Standards Program
FDA

Moderator

Jon Speer
Founder & VP QA/RA
Greenlight Guru

About greenlight guru

Greenlight Guru is a modern quality management software platform used by medical device companies in over 600 cities and 35 countries to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based eQMS,

Greenlight Guru is easier to implement, easier to use and simply fits medical device processes out-of-the-box allowing companies to innovate faster and be more efficient. Visit our home page to learn more.

ABOUT EISNER SAFETY CONSULTANTS

Eisner Safety Consultants provides affordable, on-time product approvals via safety & regulatory agencies to medical device companies. We provide assistance with U.S., Canadian, European, & other international regulations. Click here to learn more about all the services they offer.

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 providers 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.

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

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