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Jan 17, 20245 min read
Medical Device Regulations India - Frequently Asked Questions (FAQs)
Frequently asked questions (FAQs) regarding medical device registration and regulations in India
Oct 23, 20236 min read
The Q-Submission Meetings for Medical Devices with US FDA
The US Food and Drug Administration (US FDA) Q-Submission Program serves as a vital channel for medical device manufacturers to engage...
Oct 21, 20233 min read
Local Representative for MDR in Mexico:Mexican Registration Holder (MRH) for COFEPRIS Communications
In recent years, Mexico has emerged as a highly attractive destination for businesses looking to expand their operations, particularly in...
Oct 15, 20236 min read
Medical Devices Regulations in Mexico: COFERIS QMS compliance Requirements under NOM-241-SSA1-2021
Mexico, a thriving and expanding market for medical devices, presents its distinct regulatory framework that manufacturers must adeptly...
Oct 9, 20234 min read
Understanding the Role of PRRC under EU MDR and IVDR
The advent of the EU Medical Device Regulations (EU MDR) and In-Vitro Diagnostic Regulation (IVDR) signals a new era of intensified...
Oct 2, 20235 min read
Key Players in Medical Device Regulation: Economic Operators under EU MDR and IVDR
In the rapidly evolving landscape of medical device regulations, understanding the roles and responsibilities of economic operators is...
Sep 30, 20233 min read
Class I Medical Devices and CE Marking: Compliance Essentials
The European Union (EU) boasts one of the most stringent regulatory frameworks for medical devices in the world. For manufacturers...
Sep 28, 20234 min read
Certifying Medical Devices in the EU: The Crucial Role of Notified Bodies under MDR and IVDR
In the ever-evolving world of medical devices, Notified Bodies play a pivotal role in ensuring the safety and efficacy of products...
Sep 27, 20234 min read
The CE Mark is Just the Beginning: Post-CE Compliance under EU MDR
The introduction of the European Union Medical Device Regulation (EU MDR) 2017/745 marked a significant milestone in the world of medical...
Sep 24, 20236 min read
Deciphering Medical Device Risk Classification Under EU MDR
The European Union Medical Device Regulation (EU MDR) represents a significant overhaul of the regulatory framework for medical devices...
Sep 23, 20235 min read
Navigating the EU MDR Labelling Requirements: A Comprehensive Guide
The European Union Medical Device Regulation (EU MDR) has ushered in a new era of regulatory compliance for medical device manufacturers....
Sep 21, 20237 min read
Understanding System and Procedure Packs in Accordance with EU MDR
In the realm of modern healthcare, the role of system and procedure packs cannot be overstated. These packs serve as invaluable tools,...
Sep 17, 20238 min read
Regulation of Reprocessed Single-Use Devices (SUD) under EU MDR
"Reprocessing" denotes a series of procedures conducted on a previously used device to enable its safe reuse. This encompasses cleaning,...
Sep 15, 20234 min read
Conformity Assessment of Medical Devices under EU MDR
The world of medical devices is a realm of constant innovation, where the development of new technologies has the power to transform...
Sep 11, 20233 min read
Demystifying the Role of Indian Authorized Agents in Medical Device Registration
In the intricate landscape of medical device regulations in India, the role of the Indian Authorized Agent (IAA) stands as a pivotal link...
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