We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug News
    • Trending
    • Commercial Operations
    • GMPs
    • FDA Enforcement Actions
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Drug Weekly
    • FDAnews
  • Device News
    • Trending
    • Commercial Operations
    • FDA Enforcement Actions
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Device Weekly
    • FDAnews
  • Books
    • FDAnews Books Library
    • Drug Books
    • Device Books
  • Training/Events
    • Webinar Training Pass
    • Events
  • Resources
    • Form 483s Database
    • FDA Approved Drugs
    • eCFR and Guidances
    • White Papers
  • CenterWatch
  • About Us
    • The Company
    • FDAnews Editorial Board
    • Contact Us
  • Advertising
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Store » Device Products » Medical Imaging - Webinar Recording/Transcript

Other Options

USB Audio Recording/Transcript - March 19, 2019

$287.00

USB Audio Recording/Transcript - March 19, 2019

$258.00

USB Audio Recording/Transcript - March 19, 2019

$244.00

USB Audio Recording/Transcript - March 19, 2019

$230.00

USB Audio Recording/Transcript - March 19, 2019

$215.00

Medical Imaging - Webinar Recording/Transcript

$287.00
Device Products

Product Details

Medical Imaging: Latest Regulatory, Compliance and Quality Developments

“AI based diagnostic imaging approaches provide an opportunity to improve patient prognosis, identify digital biomarkers of early response to treatment, or develop novel clinic-genomic phenotypes that could be used to triage patients for routine scans based on their likelihood of eventually developing an aggressive cancer.

Toward these goals, the FDA is exploring the use of a neutral third party to collect large annotated imaging data sets, for example highly annotated radiology scans used in a variety of clinical trials for specific disease indications.”

— Lauren Silvis, FDA Chief of Staff

As electronic technology advances, its integration into medical devices — specifically medical imaging devices — challenges the FDA to regulate the integrated devices and still allow new technologies to the market in a reasonable time.

J. Lawrence Stevens, RAC — an expert witness for cases involving FDA compliance for medical devices — will discuss the latest FDA trends and how to keep your company competitive. After attending this webinar, you’ll understand:

  • The nuances of the latest in FDA premarket and post market requirements for medical imaging devices including:
    • Ultrasound Imaging
    • MRI (Magnetic Resonance Imaging)
    • Pediatric X-ray Imaging
    • Medical X-ray Imaging
    • Radiography
    • Computed Tomography (CT)
    • Dental Cone-beam Computed Tomography
    • Fluoroscopy
    • Mammography
  • How to comply with Title 21 – Food and Drugs, Chapter 9, FA&C Act, Subchapter V, Drugs and Devices
  • How to comply and interpret FDA’s Guidance on Display Devices for Diagnostic Radiology – Guidance for Industry and Food and Drug Administration Staff Issued Date 10/02/17
  • What the recent article, “The Long Run Is Now: How FDA is Advancing Digital Tools for Medical Product Development,” by Lauren Silvis, FDA Chief of Staff means for medical imaging regulation

This is your chance to hear from an expert on FDA medical device regulation on how the FDA is using its authority in the new generation of medical imaging devices.

  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell or Share My Data
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing