FDA’s Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices

| May 10, 2016

WHAT DOES IT MEAN TO ME?

The Digital Pathology Association 2016 Webinar Series – Session 2
Available to Members Only
Thursday, May 25, 2016 | 1pm EST

Learn more about the newly released FDA Guidance for Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices. What does it mean to you? Members of the DPA Regulatory Taskforce who have been in active dialogue with the Food and Drug Administration, along with a panel of Technical Representatives from DPA’s Benefactor members, and legal counsel, will participate. The webinar will address:

  • Technical contents and how to deal with it both by testing and description;
  • Regulatory and how such information goes into a submission;
  • The legalities of a guidance document.

Presenters include:

Esther Abels

Esther Abels, Director Quality & Regulatory and Medical Affairs, Philips

Montalto_bio_pic

Michael Montalto, PhD, Chair SVP, Clinical, Medical & Scientific Affairs, Omnyx LLC

Along with Technical Representatives from Leica, Omnyx, Philips, and Roche, and Legal Counsel

Members register now for free at www.digitalpathologyassociation.org

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Category: Advocacy, Anatomic Pathology, Business, Clinical Laboratories, Clinical Pathology, Device Manufacturers, Digital Pathology News, Education, Government, Informatics, Laboratory Compliance, Pathology News, Standards and Guidelines, Web/Tech, Webinars, Whole slide

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