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AUSTIN, Texas (PRWEB) February 03, 2020
Emergo by UL, a global medical device and healthcare technology consultancy, has rolled out 510(k) Builder, a new subscription-based software tool to simplify and streamline medical device manufacturers’ FDA 510(k) submissions in order to obtain faster US market access.
Available through Emergo by UL’s Regulatory Affairs Management Suite (RAMS) automated medical device registration and compliance platform, 510(k) Builder provides step-by-step support for preparing and compiling a complete Premarket Notification submission according to FDA requirements.
Key features of 510(k) Builder include:
FDA 510(k) submission generation typically involves manual preparation and compiling of hundreds of documents; oversights and errors can result in delayed clearance and increased market entry costs for device manufacturers.
“Inconsistencies and omissions in 510(k) premarket submissions can lead to substantial delays for US market applicants, especially when these errors pertain to Indications for Use, product name and related data,” explains Elizabeth Manning, Program Manager at Emergo by UL. “We’ve developed 510(k) Builder to help medical device manufacturers realize more efficient submission generation, plus reduce costly delays in obtaining 510(k) clearance.”
Emergo by UL’s Regulatory Affairs Management Suite (RAMS) software service provides digital tools and insights to help medical device manufacturers monitor regulatory changes, efficiently and cost-effectively prepare FDA 510(k) submissions, and manage device registrations and renewals. Learn more about our automated RA/QA platform at EMERGObyUL.com/RAMS.
About Emergo by UL
EMERGO by UL is a leading regulatory consulting firm specializing in global medical device and IVD compliance. Our comprehensive solution is designed to help you achieve and maintain regulatory and commercial success. With a presence on six continents, we can provide real-time service and on-the-ground expertise. Learn more about how we can help you grow at EMERGObyUL.com.
For the original version on PRWeb visit: https://www.prweb.com/releases/emergo_by_ul_launches_510k_builder_for_streamlined_us_fda_medical_device_submissions/prweb16878092.htmNEXT ARTICLE
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