Navigation Links
FDAnews Announces — FDA CDS Software Regulation: The Latest Guidance on Clinical Decision Support Software Webinar, April 7, 2020
Date:4/2/2020

FDA CDS Software Regulation:
The Latest Guidance on Clinical Decision Support Software
An FDAnews Webinar
Tuesday April 7, 2020, 1:30-3:00 p.m. EDT
https://www.fdanews.com/cdssoftwareregulation

*NEW: The webinar will be updated to include FDA regulation of AI used to guide clinical management of the Coronavirus.*

Is one’s software regulated as a medical device?

Does it provide computerized alerts and reminders for providers and patients, documentation templates, diagnostic support or contextually relevant reference information? Then, the software might be regulated as a medical device.

Join FDAnews and legal expert Bradley Merrill Thompson for a comprehensive overview of the latest legal, regulatory and compliance nuances of FDA’s guidance on clinical decision support (CDS) software:

•Master the legal, regulatory, and compliance nuances of the FDA’s guidance
•Determine what types of CDS software functions do not meet the definition of a device as amended by the Cures Act
•Assess which types of software meet the definition of a device for which the FDA may not enforce compliance under device requirements
•Comprehend how the FDA intends to leverage the Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations External Link Disclaimer (IMDRF Framework) in its risk-based approach to CDS regulation

Establish compliant best practices for CDS software by understanding the legal, regulatory and compliance nuances of the FDA’s guidance.

Webinar Details:
FDA CDS Software Regulation:
The Latest Guidance on Clinical Decision Support Software
An FDAnews Webinar
Tuesday April 7, 2020, 1:30-3:00 p.m. EDT
https://www.fdanews.com/cdssoftwareregulation

Tuition:
$287 per site

Easy Ways to Register:
Online: https://www.fdanews.com/cdssoftwareregulation
By phone: 888.838.5578 or 703.538.7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations

Read the full story at https://www.prweb.com/releases/fdanews_announces_fda_cds_software_regulation_the_latest_guidance_on_clinical_decision_support_software_webinar_april_7_2020/prweb17024791.htm.


'/>"/>
Source: PRWeb
Copyright©2020 Vocus, Inc.
All rights reserved


Related medicine news :

1. FDAnews Management Report: Managing Contract Manufacturers and Testing Labs
2. FDAnews Management Report: Implementing Risk-Based Verification and Validation
3. FDAnews Announces CDRH’s Office of Compliance Reorganization: A “One-On-One” with Office Director Steve Silverman, Webinar, Feb. 5, 2014
4. FDAnews Announces Device Software Verification and Validation: Get Ready for a New Breed of Investigators, On-Demand Webinar, Aug. 12, 2014
5. FDAnews Announces — Improving Your FDA Import Success Rate: Tips for Thinking Ahead of the FDAWebinar, Aug. 7, 2014
6. FDAnews Announces — Choosing the Right Drug Name: How to Increase Your Chances for Approval Webinar, July 22, 2014
7. FDAnews Announces — New Job Board Now Available on FDAnews.com
8. FDAnews Workshop: Conducting Advanced Root Cause Analysis CAPA Investigations, Sept. 17-18, 2014, Raleigh, NC
9. FDAnews New Workshop, 2 Weeks to Register — Innovative Process Validation Strategies for Medical Devices, Aug. 26-27, 2014, Bethesda, MD
10. FDAnews Announces Choosing the Best Device Sample Size for Verification and Validation: Tools to Safely Speed Your Device to Market, On-Demand Webinar, Aug. 27, 2014
11. FDAnews Announces — What to Do Now for UDI: Don’t Lose Your Customers by Getting Locked Out of the Market Webinar, Sept. 9, 2014
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/30/2020)... ... May 29, 2020 , ... Worldwide Business with kathy ireland® will be LIVE ... and Wednesday, June 3, 2020 at 8:00pm ET / PT – two chances to watch ... IQ Med , and Diagnostic Solutions Laboratory . , As leaders ...
(Date:5/28/2020)... (PRWEB) , ... May 28, 2020 , ... ... healthcare organization is joining the clinically integrated network (CIN) and the group purchasing ... with AHN’s Cardiovascular Institute to establish a heart failure program at Mon Health ...
(Date:5/27/2020)... Mich. (PRWEB) , ... May 27, 2020 , ... The ... Covid-19 curve and Howell Michigan, Fowlerville Michigan , and Ann Arbor Michigan. ... seeing all high-risk patients within the clinic and at the hospital. We have been ...
(Date:5/26/2020)... LIVONIA, Mich. (PRWEB) , ... ... ... and RevSpring today announced the availability of two leading RevSpring solutions—Talksoft® patient ... Loyale Patient Payment platform by engaging patients through automated and precise texts, ...
(Date:5/25/2020)... NAPA, Calif (PRWEB) , ... May 23, 2020 , ... ... of the moment. We wanted to present something whimsical and delicious in these complicated ... 2018 Red Wine Blend ($34.99) and 2018 Grenache ($24.99). The Chardonnay and Red Wine ...
Breaking Medicine News(10 mins):
(Date:6/2/2020)... ... June 02, 2020 , ... As the leading human ... to COVID-19 it is working with its corporate team, its consultants, and its ... a host of digital resources. Harmony’s leadership team recognized the extraordinary efforts of ...
(Date:6/2/2020)... ... 02, 2020 , ... SCFHP members who call SCFHP’s 24/7 nurse advice line ... the inquiry, can now virtually consult with an available physician. Once the consultation is ... doctor to ensure seamless care. The nurse advice line with the new telehealth feature, ...
(Date:5/30/2020)... ... , ... Impiger Technologies, a Texas based software solutions organization, ... to help organizations safely return their employees to the workplace. ... screenings, social distancing support, and contact tracing at work. With this data, companies ...
Breaking Medicine Technology: