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What Regulatory, Quality and Compliance Professionals Need to Know Webinar June 22, 2021

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WCG FDAnews

WCG FDAnews


FALLS CHURCH, Va. (PRWEB)

FDA’s Plan to Modernize the 510(k) Pathway:

What Regulatory, Quality and Compliance Professionals Need to Know

An FDAnews Webinar

Tuesday, June 22, 2021, 1:30 p.m.-3:00 p.m. EDT

https://wcg.swoogo.com/fda-plan-to-modernize-the-510k-pathway

Want to streamline the 510(k) processes and shorten the timeline to clearance? The FDA is modernizing the 510(k) framework, meaning even if one’s methods are in order, the pathway is about to change.

Avoid the common mistakes many make with 510(k)s and adjust now to the FDA’s evolving expectations with this webinar.

Mary Vater, an experienced biomedical engineer serving as a medical device consultant specializing in regulatory affairs, will share current best practices and tips for submitting 510(k)s, the FDA’s changes and how to keep your 510(k)s on track, explaining:


  • Specific changes the FDA made to the 510(k) process including implications for companies choosing predicates cleared more than a decade ago

  • How to identify suitable and favorable predicate devices by identifying similar or competitor products and going beyond the premarket comparison

  • How to determine what type of adverse events are common in one’s product classification so one can select a predicate with a relatively clean history

  • How to deal effectively with new challenges, including the possible need for additional testing to reflect postmarket information for your device classification

  • How to overcome specific challenges in creating and executing a sufficient test plan, including identifying all of the relevant standards and guidances and looking into the most recently cleared devices within your product code

  • What the best time is to file your presubmission within the development process, and the right questions to ask to gain the most value from your meeting

  • Understand and use third-party reviewers per the FDA’s new 510(k) Third Party Review Program issued in March

  • How to stay current and find the latest FDA guidance and enforcement policies

It’s about to become even more of a challenge to obtain 510(k) clearances. Facilitate 510(k)s and consolidate the timeline.

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’s Plan to Modernize the 510(k) Pathway:

What Regulatory, Quality and Compliance Professionals Need to Know

An FDAnews Webinar

Tuesday, June 22, 2021, 1:30 p.m.-3:00 p.m. EDT

https://wcg.swoogo.com/fda-plan-to-modernize-the-510k-pathway

Tuition:

$287 per site

Easy Ways to Register:

Online: https://wcg.swoogo.com/fda-plan-to-modernize-the-510k-pathway

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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