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Understanding UDI

WEBUS FDA & UDI FUNDAMENTALS. The Global Unique Device Identification Database, also known as GUDID is governed by US FDA. Since its origins in 2013, the goal of GUDID …

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URL: https://go.reedtech.com/understanding-udi-usa

Understanding UDI Series

WEBThe UDI is created through an approved issuing agency. This identifier, along with additional product data elements are part of the Health Authority submission requirement.

Category: Health Go Health

Reed Tech Webinar FDA Class I UDI Requirements & Exemptions

WEBJoin our panel, including Terrie Reed, former UDI lead at the FDA, for a walk-through of the US FDA Class I medical device UDI requirements, exceptions, and use cases. Our …

Category: Medical Go Health

Where Are We Now

WEBAs we review the long-awaited Health Canada XML PM Guidance Documents, and what that means for industry, Reed Tech subject-matter expert, Gary Saner, revisits what we …

Category: Health Go Health

How To Navigate Health Canada XML PM Requirements

WEBAs we enter 2021, these Health Canada mandates and timelines become more important than ever. Join the experts at Reed Tech for a webinar detailing what you need to know …

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What’s Been Happening with Health Canada XML PM Mandates

WEBReed Tech Life Sciences. 7 Walnut Grove Drive Horsham, PA 19044 +1-215-557-3010

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Reed Tech eCTD Services

WEBThe Electronic Common Technical Document (eCTD) is the standard format for submitting regulatory submissions to the U.S. Food and Drug Administration (FDA) and other …

Category: Food Go Health

Understanding UDI

WEBThe database, known as Integrated Medical Device Information System (IMDIS) has regulatory requirements for UDI by device class and Track and Trace supply reporting. …

Category: Medical Go Health

Reed Tech Life Sciences eDRL Customer Training

WEBThis session is designed for all Reed Tech customers on the SingleSource for Drug Products. Weekly Offerings: If you are unable to attend a regularly scheduled session …

Category: Health Go Health

Medical Devices and EUDAMED UDI+ Managed Services

WEBEUDAMED (European Database on Medical Devices) is the web-based portal implemented by the European Commission to serve as a centralized database for economic operators (medical device manufacturers worldwide, designated representatives and system/procedure pack providers) for the registration and required EU regulatory …

Category: Medical Go Health

MoCRA-Cosmetic Regulations and Facility Registration

WEBThe Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was signed into law on December 29, 2022. This law, which provides a major overhaul of existing cosmetic …

Category: Health Go Health

Reed Tech WEBINAR Upskill with Reed Tech: SPL Basics and Beyond

WEBCurrent FDA SPL Requirements. The future of SPL. Register Now to view the recording of the webinar, Upskill with Reed Tech: SPL Basics and Beyond! Reed Tech is a …

Category: Health Go Health

China's Expanding Medical Device

WEBRegister to view the live webinar brought to you by Reed Tech and Cisema: China's Expanding Medical Device UDI Requirements . UDI data requirement expert Gary Saner …

Category: Medical Go Health

Uncovering Complexities: Health Canada Labeling

WEBRegister to join us Thursday, July 29th at 2 PM ET when we take a high-level look into what pharmaceutical regulatory teams in Canada need to know about the complexities of drug product coding and labeling into XML and why they should get started now.

Category: Health Go Health

Health Canada XML Product Monograph for Drug Information

WEBHealth Canada has created an initiative to adopt a structured product monograph format to increase efficiency and provide Canadians with more relevant and concise drug product …

Category: Health Go Health