FDAnews Announces FDA Digital Health Regulation: Latest Developments for Medical Device Manufacturers Webinar April 8, 2021

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Prepare to comply with the latest SaMD FDA digital health regulation developments. Webinar provides expert guidance. Register today.

WCG FDAnews

WCG FDAnews

FDA Digital Health Regulation:
Latest Developments for Medical Device Manufacturers
An FDAnews Webinar
Thursday, April 8, 2021 • 1:30 p.m. – 3:00 p.m. EDT
https://www.fdanews.com/cder2021guidance

How does one prepare to apply the latest digital health regulations to software-intensive medical devices? How does one become familiar with the digital tools available to increase reproducibility? How does one become skilled in using real-world monitoring of software devices to increase your compliance?

If a software on a medical device platform is being used, in an off-the-shelf product or on a virtual network, one needs to understand the latest developments in regulations.

With this webinar, attendees will be able to determine the differences between traditional medical device regulations and software as a medical device (SaMD) regulations. Learn the unique risks that software-intensive medical devices pose to the healthcare ecosystem and figure out how to build regulatory practices directly into the systems development lifecycle. One will also gain methods for easing audit and inspection burdens.

This webinar will cover:

  • SaMD Regulation Details

a. The differences between traditional medical device regulations and SaMD regulations
b. The unique and novel risks software-intensive medical devices pose to the healthcare system

  • Challenges and Opportunities

a. Difficulties and benefits that can come from SaMD versus 510(k) compliance
b. Ways to ask product managers, engineers and other development professionals for proof of safety and efficacy

  • SaMD-related Tools

a. A new RegOps approach that could allow regulatory artifacts to be generated as byproducts of the SaMD development effort
b. How automated RegOps could reduce preparation time for FDA submissions

  • The Systems Development Lifecycle

a. How building regulatory practices directly into the systems development lifecycle could ease inspection and audit burdens
b. Creating more reliable results through directly building in regulatory practices

Don’t let the FDA’s increased scrutiny and growing regulations get in the way of the success of software-intensive devices. Discover what one needs to know during this webinar.

Interested in registering multiple sites?
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
to learn about our special multisite discount.

Webinar Details:
FDA Digital Health Regulation:
Latest Developments for Medical Device Manufacturers
An FDAnews Webinar
Thursday, April 8, 2021 • 1:30 p.m. – 3:00 p.m. EDT
https://www.fdanews.com/cder2021guidance

Tuition:
$287 per site

Easy Ways to Register:
Online: https://www.fdanews.com/cder2021guidance
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

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Michelle Butler
FDAnews
703.538.7600
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