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10Mar 2025
EU, Regulations, Swiss, UK Cubicdesignz

SaMD Devices Classification

SaMD is software intended for one or more medical purposes that perform these without being part of a hardware medical device. Medical device software is meant to be used, alone or in combination, for a purpose specified in the definition of a “medical device” in the MDR or IVDR, regardless of whether the software is independent or driving or influencing the use of a device. You can read more on the SaMD Regulation here. To be qualified as medical device software, the product must first...
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10Mar 2025
Regulations Cubicdesignz

MHRA Guidance on Stand-alone Software Medical Devices

Medical device apps are increasingly growing these days. MHRA has issued new guidance on the stand-alone software medical devices, including apps. This guidance is a crucial document for manufacturers and users of such medical devices. In the UK, medical devices are subject to UKCA marking. The UKCA marking is no exception to software medical devices. MHRA Guidance on Medical Devices Software Medical Devices or not Classifying software or a mobile app as a medical device can be challenging. If t...
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10Mar 2025
General Information Cubicdesignz

Global Market Access Strategies for Software as a Medical Device (SaMD)

Introduction In the ever-evolving realm of healthcare technology, Software as a Medical Device (SaMD) stands out as a transformative force, offering personalized solutions tailored to individual patient needs. As demand surges for SaMD solutions worldwide, understanding and navigating international regulations are paramount for market access success. This article explores global strategies for achieving market access for SaMD, delving into the intricacies of international regulations and conform...
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10Mar 2025
FDA, EU, EU MDR, Regulations, USA Cubicdesignz

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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10Mar 2025
FDA Cubicdesignz

FDA Post-Market Surveillance (PMS) for Medical Devices

FDA Post-Market Surveillance (PMS) is a regulatory requirement under 21 CFR Part 822, designed to ensure the long-term safety and effectiveness of medical devices after they have been released into the market. It helps manufacturers identify potential risks, track real-world device performance, and take necessary corrective actions to maintain compliance with FDA PMS regulations. What is FDA Post-Market Surveillance (PMS) for Medical Devices? FDA PMS refers to the systematic monitoring of medica...
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UDI system - South Korea's Medical Device
06Mar 2025
Blogs, South Korea, Trending Now admin

Korea’s Unique Device Identification (UDI) System: What You Need to Know? 

In recent years, South Korea has implemented a comprehensive Unique Device Identification (UDI) system for medical devices, aiming to enhance patient safety, improve traceability, and align with global standards. As of 2025, understanding and complying with the Ministry of Food and Drug Safety (MFDS) UDI requirements is essential for manufacturers and importers seeking to market medical devices in the Korean healthcare sector.  What is UDI System? The UDI system in South Korea was introduced to...
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06Mar 2025
China, Blogs, Trending Now admin

Step by Step Process in Medical Device Registration China

Registering medical devices in China is a complex and highly regulated process governed by the National Medical Products Administration (NMPA). Manufacturers seeking market entry must comply with stringent regulatory requirements to ensure safety, efficacy, and compliance.   The Centre for Medical Device Evaluation of NMPA (CMDE) shall be responsible for the application for clinical trials of medical devices requiring clinical trial approval, and the technical evaluation of the registration ap...
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05Mar 2025
News admin

February Newsletter 2025 – English

We’re excited to bring you the latest updates and expert insights in our February 2025 Newsletter. Stay informed about key regulatory changes, industry advancements, and compliance updates in the medical device and cosmetics sectors. What’s Inside This Month? 🔹 Regulatory Updates for Medical Devices – Stay ahead with the latest changes in compliance and medical device regulations. 🔹 Cosmetics Industry Trends & Safety Standards – Discover emerging trends and updated safety requi...
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05Mar 2025
News admin

February Newsletter 2025 – Simplified Chinese

We’re excited to bring you the latest updates and expert insights in our February 2025 Newsletter. Stay informed about key regulatory changes, industry advancements, and compliance updates in the medical device and cosmetics sectors. What’s Inside This Month? 🔹 Regulatory Updates for Medical Devices – Stay ahead with the latest changes in compliance and medical device regulations. 🔹 Cosmetics Industry Trends & Safety Standards – Discover emerging trends and updated safety requi...
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how to prepare technical file for Saudi
04Mar 2025
Blogs, SFDA, Trending Now admin

How to Prepare a Technical File for SFDA Medical Device Registration?

A technical file for SFDA medical device registration is a key document that proves a device’s safety, quality, and compliance with the Saudi Food and Drug Authority (SFDA) regulations. A well-prepared file ensures a smoother approval process and faster market entry. This guide outlines the essential steps and best practices to compile a technical file as per SFDA’s latest 2025 requirements. What is Technical File in Medical Devices? A technical file is a structured document that includes es...
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