October 26, 2021

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How to Get Your 510(k) Approved on Your First Try (And Why Only 31% Succeed), Upcoming Webinar Hosted by Xtalks

How to Get Your 510(k) Approved on Your First Try (And Why Only 31% Succeed), Upcoming Webinar Hosted by Xtalks

How to Get Your 510(k) Approved on Your First Try (And Why Only 31% Succeed), Upcoming Webinar Hosted by Xtalks

How can a submission be constructed in a way that’s least likely to be rejected?

Did you know that between January and June of 2015, 69% of 510(k) applications were rejected their first time? Even though there have been significant changes to the content required in a 510(k) submission since the agency released their guidance in 2005, this should not be the case. So, what can be done to better manage a team’s 510(k) expectations? How can a submission be constructed in a way that’s least likely to be rejected?

Register for this webinar to hear about the common pitfalls that plague first-time medical device founders when submitting their device to the FDA and share the secrets of industry veterans who have mastered the art of regulatory clearance.

Join Jon Speer, Founder & VP QA/RA, Greenlight Guru, for the live webinar on Wednesday, October 6, 2021 at 11am EDT (4pm BST/UK).

For more information, or to register for this event, visit How to Get Your 510(k) Approved on Your First Try (And Why Only 31% Succeed).

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year, thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit http://xtalks.com

For information about hosting a webinar visit http://xtalks.com/why-host-a-webinar/

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