Simplifying Global Compliance
Medical Imaging - Webinar Recording/Transcript
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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.
- CEO’s
- VP RA/QA
- VP R&D
- Directors of RA
- Directors of R&D
J. Lawrence Stevens, RAC
Mr. Stevens has over 20 years of FDA experience encompassing virtually all of the FDA field positions. He also has eighteen years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the medical device industry. He currently serves as an expert witness for cases involving FDA regulation compliance for medical devices. He regularly performs webinars regarding FDA and issues regarding clinical studies and medical devices.
