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Medical device

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Tag: Medical device
kimes busan
09Oct 2024
Events admin Comments: 0

KIMES Busan Medical & Hospital Equipment Show

The KIMES Busan Medical & Hospital Equipment Show is a premier event in South Korea’s medical industry, showcasing the latest advancements in medical technology, hospital equipment, and healthcare solutions. Held annually in Busan, KIMES Busan attracts healthcare professionals, medical equipment manufacturers, and industry leaders from around the world, creating an ideal platform for networking, discovering new technologies, and expanding knowledge in the healthcare sector. Key Highlights...
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China International Medical Equipment Fair
08Oct 2024
Events admin Comments: 0

China International Medical Equipment Fair (CMEF)

Introduction The China International Medical Equipment Fair (CMEF) is one of the largest and most influential medical equipment exhibitions in Asia, bringing together healthcare professionals, manufacturers, distributors, and innovators from around the world. Held biannually, CMEF showcases a wide array of medical devices, diagnostics, imaging systems, wearables, and other healthcare solutions. It serves as a platform for product launches, industry networking, and gaining insights into advanceme...
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September Newsletter
03Oct 2024
News admin Comments: 0

September Newsletter 2024 – Traditional Chinese

We look forward to sharing the latest updates and insights in our September Newsletter 2024 – Traditional Chinese. What’s inside!! 1. The latest information on medical device regulations and compliance 2. Cosmetics safety standards and industry trends 3. List of Updated ISO Standards for September 2024 Please read below for more information. September Newsletter Traditional Chinese...
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Medicinal Products for Human
30Sep 2024
Blogs, General Information admin Comments: 0

Labelling and Packaging of Medicinal Products for Human use following Agreement of the Windsor Framework

1. Overview This guidance aims to outline the labelling and packaging requirements for medicinal products intended for human use, following the agreement of the Windsor Framework. It should be used alongside the existing guidance for wholesale dealers and manufacturers. The Windsor Framework establishes long-term arrangements for the distribution of medicines in Northern Ireland. It ensures that medicines can be approved and licensed throughout the UK by the Medicines and Healthcare products Reg...
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In-Vitro Diagnostics
12Aug 2024
WhitePapers admin Comments: 0

Whitepaper: The Future of the Global In-Vitro Diagnostics (IVD) Market: Trends, Challenges, and Opportunities

This white paper explores the global In-Vitro Diagnostics (IVD) market, focusing on the next five years. It covers the most sold devices, countries with high procurement, complexities faced by manufacturers, market evolution, and the impact of regulations. The insights provided are based on current market trends and data. Topics Covered in this Whitepaper 1. Introduction 2. Overview of the Global In Vitro Diagnostics Market 3. Complexities Faced by Manufacturers 4. Evolution of IVD Market 5. Imp...
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13Jul 2024
Swiss, Select Swiss AR Swiss AR Cubicdesignz Comments: 0

What makes Switzerland significant for Medical Device Manufacturers?

Switzerland is a premier destination for medical device manufacturers relying on sophisticated micromanufacturing or advanced precision techniques. This appeal is evident in Switzerland’s choice of EMEA headquarters for industry leaders. The country boasts one of the world’s highest proportions of GDP derived from the manufacturing sector, driven by traditional watchmaking, MEMS, and Medtech industries. These sectors have cultivated highly industrialized, digitized precision cluste...
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13Jul 2024
SFDA Cubicdesignz Comments: 0

Unlocking Opportunities: Understanding Saudi Arabia’s Medical Device Approval

Introduction The Saudi Arabian Medical device registration and approval is governed by the Saudi Food and Drug Authority, also known as the SFDA. The procedure for the introduction of a medical device in the Saudi Arabian market is called Medical Device Marketing Authorization (MDMA). SFDA has published a guidance document, MDS-REQ-001, on Requirements for Medical Device Marketing Authorization. This guidance provides detailed information on the authorization process. Saudi Arabian Medical Devic...
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13Jul 2024
FDA, EU, EU MDR, Regulations, USA Cubicdesignz Comments: 0

Software As a Medical Device and Its Clinical Evaluation

As technology advances across all healthcare fields, Software plays a significant role in all products. It is widely integrated into digital platforms serving both medical and non-medical purposes. Medical device software is one of three types of Software related to medical devices. The other two types of medical device software include Software that is an integral part of the medical device (medical device software) and Software used in manufacturing or maintaining the medical device. Software...
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12Jul 2024
General Information Cubicdesignz Comments: 0

Product Liability Insurance for Medical devices

Medical devices are subject to product defects. These product defects arise due to design, manufacturing or even a failed instruction for use of a product. These defects can cause risks to patients, who in turn can sue the manufacturer for the damages caused. As medical device manufacturers, it is imperative to choose insurance that best covers themselves as well as their affiliates. Product liability was brought in place to ensure that potentially unsafe products are discouraged from being plac...
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12Jul 2024
General Information Cubicdesignz Comments: 0

Definition of a Medical Device around the global market

What is a Medical Device? The simplest definition of a medical device is a product used for treatment except for medicines. It is imperative to understand if the product classifies as a medical device and apply the regulations after defining it properly. An essential aspect of defining a medical device is its intended use. Intended use is the purpose of the device specified by the manufacturer. In this article, we have brought up the definition of “medical device” for a few major countries....
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