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CE Marking

Learn how to achieve CE Marking & EU MDR compliance with our comprehensive guide. Stay updated and navigate the regulatory requirements efficiently.

Risk Management As Per ISO 14971

Risk Management of Medical Devices in Accordance with ISO 14971:2019

1 Comment / Regulatory Compliance Guide | By MedDev Experts, CE Marking, Medical Device Rule, US FDA /

Risk Management of Medical Devices in Accordance with ISO 14971:2019 This article is to assist manufacturers of medical devices to identify the hazards associated with the medical device, including software as a medical device, and in vitro diagnostic medical devices to estimate and evaluate the associated risks, control these risks, and monitor the effectiveness of […]

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CDSCO Device Master File by Meddev Expert

CDSCO Device Master File for Medical Device: Indian MDR 2017

3 Comments / CE Marking, Medical Device Rule, US FDA /

CDSCO Device Master File for Medical Devices The Device Master File for Medical Devices is a comprehensive and confidential document to provide technical information about the products to regulatory authorities. This document serves as a critical reference during the regulatory review process, enabling authorities to assess the safety, effectiveness, and quality of the medical devices

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various medical device symbols displayed in a banner

Essential Medical Device Symbols for Labeling: A Comprehensive Guide As Per ISO 15223-1

2 Comments / CE Marking, Medical Device Rule, US FDA /

Essential Medical Device Symbols for Labeling: A Comprehensive Guide as per ISO 15223-1 Medical Device Symbols are essential for conveying vital information on medical devices. When deemed appropriate, symbols can be marked on the device, packaging, or associated documentation. Manufacturers must ensure the symbols are of a suitable size for clear legibility. Before implementing symbols,

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A medical device label with all required symbols designed by MedDev Experts

Medical Device Labeling Requirements

Leave a Comment / CE Marking, Medical Device Rule /

EU MDR Medical Device Labeling Requirements The EU MDR 2017/745, introduced by the European Parliament and the Council of the European Union in 2017, aims to enhance safety and quality standards for medical devices in the European Union. It replaces the older Medical Device Directives (EU MDD) and Active Implantable Medical Device Directives (AIMDD), bringing

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EU Declaration of Conformity: How to Comply with new Medical Device Regulation (EU) 2017/745

Leave a Comment / CE Marking, Medical Device Rule /

EU Declaration of Conformity: How to Comply with new Medical Device Regulation (EU) 2017/745 Overview of Declaration of Conformity: The EU Declaration of Conformity is an official document through which the manufacturer confirms that the device meets the essential requirements mentioned in Annex IV of Regulation (EU) 2017/745 of the European Parliament and of the

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