Industry Update – Guidance Document published by FDA for Small Entities

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Small Entity Compliance Guide – Guidance Document published by FDA FDA published a final rule in the Federal Register entitled “Medical Devices; Laboratory Developed Tests” (“LDT Final Rule”), amending FDA regulations to make explicit that in vitro diagnostic products (IVDs)… 

Industry Update – QMSR for Medical Devices

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Quality Management System Regulation (QMSR) for Medical Devices The Quality Management System Regulation (QMSR) for Medical Devices, released by the FDA on January 31, 2024, is a significant update to the existing Quality System (QS) regulation (21 CFR Part 820).… 

HOSPEX Healthcare Expo 2023

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HOSPEX Healthcare Expo cum Conferences 2023 – SEP 15-17,2023 at Zamra International Convention Centre, Kochi, Kerala The “First, Best, and Only Hospital Expo in Kerala” for all your Medical Equipments and Hospital needs. Experience the Next Generation of Healthcare at HOSPEX… 

Cyber Security for Medical Devices

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Cyber Security Alert for Medical Devices – Announcement from USFDA Cybersecurity Vulnerability with Apache Log4j The U.S. Food and Drug Administration (FDA) is raising awareness of a cybersecurity vulnerability in Apache’s Log4j software library, versions 2.0-beta9 to 2.14.1. Log4j is… 

Webinar on Medical Devices

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FDA Overview & Tips on Identifying Predicate Device – Oct 5th 2021 – Tuesday at 5 30 pm – 6 30 pm SIIC IIT Kanpur in partnership with AIMED Invites you to a session on “FDA overview and Tips on Identifying Predicate…