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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Featured Capabilities:

Document Management Training Management CAPA Management Audit Management Product Development

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

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Accelerate development with integrated design control and risk software.

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Featured Capabilities:

Design Controls Risk Management Risk Intelligence

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Data collection and management designed for MedTech clinical trials.

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Featured Capabilities:

Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys Product Add-Ons

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FREE ON-DEMAND WEBINAR

Standards, Standards, 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.

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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?
  • Clinical Research Professionals and Management
  • Medical Device Executives
  • Regulatory Affairs Professionals and Management
  • Quality Professionals and Management
  • Clinical Affairs Professionals and Management
  • R&D Engineers and Management
 Register Now  

Hosted by

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Presenter: Leo Eisner

Principal Consultant, Eisner Safety Consultants
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Presenter: Scott Colburn

Director, CDRH Standards Program, FDA
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Presenter: Gail Rodriguez

Senior Policy Advisor, CDRH Standards Program, FDA
jon-round-new
Moderator: Jon Speer

Founder & VP QA/RA, Greenlight Guru

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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 CDHR
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. 
Visit their website to learn more.

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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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