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Introduction When it comes to entering the European Union (EU) market, CE marking is a crucial certification that signifies a medical device’s compliance with EU regulations. For medical device manufacturers, the EU Medical Device Regulation (MDR 2017/745) sets out strict guidelines to ensure safety and performance before marketing a device in Europe. As a medical […]

Introduction Navigating the European Union (EU) market requires medical device manufacturers to understand the pivotal role of Notified Bodies (NBs) in the CE marking process. This article offers a comprehensive guide on the function of NBs, criteria for selecting the appropriate one, and strategies for effective collaboration to ensure compliance with EU regulations. Understanding Notified

Introduction In the competitive landscape of medical device manufacturing, securing access to the European market is a pivotal step. Central to this process is obtaining the CE marking, a certification that signifies compliance with European Union (EU) regulations. This guide provides an in-depth exploration of CE certification, its significance, and the steps manufacturers must undertake

Introduction:India’s medical device and in vitro diagnostics (IVD) markets are witnessing rapid growth, driven by increasing healthcare demand, government initiatives, and technological advancements. The country’s regulatory framework, governed by the Central Drugs Standard Control Organization (CDSCO), plays a crucial role in ensuring the safety and efficacy of medical devices. While India remains heavily reliant on

Key Changes and Their Impact on Manufacturers At Titans Medical Consulting, we understand that staying updated with regulatory changes is crucial for medical device manufacturers to ensure compliance and smooth market entry. The Central Drugs Standard Control Organization (CDSCO) in India has introduced new guidelines in 2025 for medical device registration, which bring several key

Introduction: The healthcare industry is witnessing transformative growth, with the MedTech sector playing a pivotal role. From diagnostics to therapeutic devices, advancements in technology have dramatically improved patient outcomes. However, this growth comes with the critical need for robust regulatory frameworks that ensure safety, efficacy, and quality. In this context, regulatory harmonization between India’s Central