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Medical device

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September Newsletter
03Oct 2024
News admin

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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13Sep 2024
General Information Cubicdesignz

OMC Medical to Showcase Global Market Access Solutions at KIMES 2024 

Book time with Gayathri Ganesan: KIMES Exhibition   OMC Medical Set to Attend KIMES, Invites Participants to Meet at UK Pavilion for Uninterrupted Market Access Solutions  SEOUL, SOUTH KOREA – February 21, 2024 – OMC Medical, a leading provider of regulatory support and market access solutions for medical device, cosmetics, and pharmaceutical manufacturers, announces its participation in the Korea International Medical & Hospital Equipment Show (KIMES) from March 1...
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29Aug 2024
EU, Brazil, FDA, General Information, IVD, Regulations, Swiss, UK, USA admin

Global ISO Requirements

What is ISO? ISO – International Organization for Standardization, is the international, non-governmental body for drafting and establishing technical and non-technical standards. These standards are developed by different committees within the International Organization for Standardization. Having around 165 member states, with one representative from each, International Organization for Standardization is a global entity catering to the needs of industry requirements. Are ISO standards impor...
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In-Vitro Diagnostics
12Aug 2024
WhitePapers admin

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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17Jul 2024
Cosmetics, EU Cubicdesignz

Understanding Borderline Cosmetics in the EU

Understanding the distinctions between product classes within the European cosmetics landscape can be complex and ambiguous, often requiring input from authoritative bodies. Certain products may share similarities but fall under different regulatory frameworks. When products straddle these frameworks, they’re termed “borderline” by the European Commission (EC). Clear comprehension of a product category is vital to determine the regulatory requisites for the specific market. Dif...
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13Jul 2024
Swiss, Select Swiss AR Swiss AR Cubicdesignz

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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12Jul 2024
General Information Cubicdesignz

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

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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12Jul 2024
EU MDR, FDA Cubicdesignz

Mastering Medical Device Audits: A Roadmap to Preparedness and Compliance Excellence

Facing a medical device audit can be daunting, but with meticulous preparation and strategic responses, companies can turn this challenge into an opportunity for building a robust quality system. Tips for Mastering Medical Device Audits This article provides a detailed roadmap for mastering medical device audits, covering essential steps from internal audits to adeptly handling regulatory findings. 1. Demystifying Audits Understanding the fundamental concepts behind medical device audits is cruc...
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12Jul 2024
EU, Regulations Cubicdesignz

Regulatory Pathway for Clinical Investigation in the EU

Regulatory Pathway for Clinical investigation creates a set of clinical data that is crucial to understanding the effectiveness of a medical device. Clinical Investigation is done for previously CE marked devices or for research medical devices. Clinical Investigation is governed by a clinical investigation plan with an objective, methodology, and record keeping. Top 5 Steps involved in Clinical Investigation Step 1 Appointment of a Representative- Appoint a legal representative....
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