FALLS CHURCH, Va., Sept. 29, 2021 /PRNewswire-PRWeb/ — Digital Health Regulation:
Navigating FDA’s Rules for Software as a Medical Device
FDAnews Management Report
https://www.fdanews.com/products/category/223-

Prepare to apply the latest digital health regulations to one’s software-intensive medical devices. Get familiar with the digital tools available to increase reproducibility. Become skilled in using real-world monitoring of software devices to increase one’s compliance.

If one is building a software as a medical device (SaMD) product, one needs to understand the latest developments in regulations.

Digital Health Regulation: Navigating FDA’s Rules for Software as a Medical Device will help one pinpoint the differences between traditional medical device regulations and those used for SaMDs, along with the unique risks and challenges they present. One will discover how automated systems could improve FDA submissions process and the importance of keeping regulatory requirements in mind as one develops new software products.

In this report, readers will discover:

● The Differences Between Conventional and SaMD Regulations
        a. The new pathway for SaMD regulations
        b. Applying regulatory requirements to software-intensive devices
● The Challenges and Opportunities of SaMDs
        a. The unique and novel risks of software-intensive medical devices
        b. How software-intensive devices impact the healthcare ecosystem
        c. The difficulties and benefits of the SaMD pathway vs. 510(k) clearance
● Ways to Manage SaMD Development
        a. How automated systems could reduce preparation time for FDA
            submissions
        b. Building regulatory practices directly into systems development
            lifecycles
        c. Easing inspection and audit burdens
        d. Creating more reliable results in the SaMD development process
● How the FDA is Encouraging Digital Health Innovation
        a. The role of artificial intelligence and machine learning
        b. Discretion in regulating digital health tools and software

Don’t let the FDA’s increased scrutiny and growing regulations get in the way of the success of one’s software as a medical device. Discover what one needs to know with this management report.

Mangement Report Details:
Digital Health Regulation:
Navigating FDA’s Rules for Software as a Medical Device
FDAnews Management Report
https://www.fdanews.com/products/category/223-

Price:
$397

Easy Ways to Purchas:
Online: https://www.fdanews.com/products/category/223-
By phone: 888.838.5578 or 703.538.7600

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Media Contact

Michelle Butler, FDAnews, 703.538.7600, mbutler@wcgclinical.com

SOURCE FDAnews