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Tag: medical device regulation

How Post-Market Surveillance Enhances Medical Device Safety

Understanding Post-Market Surveillance:In the fast-paced world of medical technology, the journey of a medical device doesn’t end with regulatory approval. It continues into the...

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MDCG Guidance on Clinical Evaluation: Specific Aspects | MDCG

The new article highlights the aspects related to the content of the clinical investigation report, discusses additional considerations associated with the transitional period, and...

Cybersecurity Threat Model Implementation: FDA Requirements

The Food and Drug Administration (FDA) plays a pivotal role in safeguarding public health through the regulation of medical devices, ensuring that they are...

MDCG Guidance on Clinical Investigation: Timelines | MDCG

The new article highlights the aspects related to the timelines associated with the clinical investigations, the way they should be calculated, and other relevant...

Medical Device Lifetime: An Overview

The Integral Role of Lifetime in Medical Device Utilization The lifetime of a medical device is a critical period during which the tool must safely...

SAHPRA Guidelines on Establishment Licensing: Introduction | RegDesk

The article highlights the key points related to the licensing regime for medical device establishments. Table of content The South African...

Navigating the Future: Insights from the 13th China International Medical Device Regulatory Forum (CIMDR) and Anticipating the 14th CIMDR in 2024

As we eagerly anticipate the 14th China International Medical Device Regulatory Forum (CIMDR) from March 30 to April 4, 2024, we find ourselves reflecting...

BD Reports Fourth Quarter and Full Year Fiscal 2023 Financial Results | BioSpace

Execution of BD 2025 Strategy Driving Durable, Broad-Based Growth Q4 revenue of $5.1 billion increased 6.8% as reported and 5.9% on a currency-neutral...

RF Medical Completed the Transition to European Medical Device Regulations (MDR) for Class IIb Medical Devices | BioSpace

SEOUL, South Korea, Oct. 24, 2023 /PRNewswire/ -- RF Medical, specializing in the treatment of tumors and veins with various radiofrequency ablation products, announced today...

Understanding FDA Registered vs Cleared vs Approved vs Granted for Medical Devices – RegDesk

This article highlights the critical differences between FDA registration, clearance, approval, and granting for medical devices, offering essential...

Global Medical Device UDI Requirements: A Quick Reference Guide for United States, Europe, Canada, Japan & Australia – RegDesk

This article talks about the Unique Device Identification System for Medical Devices, its timelines and regulatory requirements across...

MDR Extension Timeline for Implementation

The extension of MDR implementation timeline has now become reality. On March 20, 2023, the Regulation (EU) 2023/607, which amends the Medical Device Regulation...

MDR Extension According to Regulation 2023/607

The extension of MDR implementation timeline has now become reality. On March 20, 2023, the Regulation (EU) 2023/607, which amends the Medical Device Regulation...

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