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12Jul 2024
General Information Cubicdesignz

Navigating Healthcare with Implant ID Cards: What You Need to Know?

Implant ID Cards Introduction Implanted medical devices, from life-saving pacemakers to pain-relieving joint replacements, are transforming how we manage health conditions. However, carrying these technological marvels within our bodies presents a unique challenge: readily accessing critical information about them when seeking medical care. This is where the power of implant ID cards comes into play. Think of these cards as miniature medical passports, discreetly holding a wealth of knowledge ab...
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12Jul 2024
General Information Cubicdesignz

Understanding the Key Responsibilities of an Authorized Representative in the Medical Device Industry

In the complex ecosystem of the medical device industry, ensuring compliance with regulatory standards and navigating the path to market access are crucial tasks. Amidst this complexity, one key player stands out: the Authorized Representative (AR). ARs are recognized globally under different titles, including Responsible Person (RP), Agent for Service of Process, Local Agent, Legal Representative (LR), and Designated Contact Point (DCP), Market Authorization Holder (MAH). Their role carries sig...
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12Jul 2024
General Information Cubicdesignz

Navigating Regulatory Requirements: Compliance Essentials for Post-Marketing Surveillance

The medical device industry thrives on innovation, but ensuring patient safety remains paramount. Regulatory compliance, particularly in post-marketing surveillance (PMS), is crucial for safeguarding patients and maintaining market access. This article explores the essentials of navigating regulatory requirements for medical devices, focusing on effective PMS practices. The Importance of Post-Marketing Surveillance Unlike pre-market testing, post-marketing surveillance monitors a device’s...
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12Jul 2024
General Information Cubicdesignz

License Transfer for Medical Device to new Local AR – New Zealand

Medical devices play a crucial role in healthcare by diagnosing, treating, and monitoring various medical conditions. These devices are designed and manufactured by companies that must obtain licenses to sell their products in different markets. When a company wants to transfer the license for a medical device to a new local Authorized Representative (AR) in a different country, such as New Zealand, there are several key steps and considerations that must be taken into account. Transferring the...
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12Jul 2024
General Information Cubicdesignz

License Transfer for Medical Device to New Sponsors from Existing License Holders

License transfer for medical devices is a crucial aspect of the regulatory landscape governing the manufacturing and distribution of medical products. It allows existing license holders to transfer the rights to manufacture and market a specific medical device to a new sponsor or entity. This process is essential for ensuring the continued availability and safety of medical devices in the market. License transfer allows for the continued availability of medical devices in the market, even as own...
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12Jul 2024
General Information Cubicdesignz

Bio Korea 2024 – The Future of Biotechnology Innovation and Global Collaboration

Every year, BIO KOREA organizes the International Convention with the goal of promoting and expanding the bio-health sector worldwide. We are happy to announce that the 19th BIO KOREA will take place at COEX in Seoul from May 8–10, 2024. This year too. Get the chance to network with international academics, professionals, and CEOs in the bio-health field, as well as exchange the latest trends and technologies in the field through BIO KOREA 2024’s Business Partnering, Invest Fair, Exhibit...
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12Jul 2024
FDA, USA Cubicdesignz

Current Good Manufacturing Practices (cGMPs) of the FDA

The FDA introduced current Good Manufacturing practices (cGMP) to maintain a system that provides proper design, monitoring, and control of manufacturing processes and facilities. The cGMP standards ensure products’ identity, strength, quality, and purity by requiring manufacturers to maintain proper control over their manufacturing processes. This system helps the manufacturer avoid as many failures and errors as possible. The “C” in cGMP refers to “current,” which...
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12Jul 2024
FDA, USA Cubicdesignz

De Novo Request | FDA

The De novo request is a simpler marketing pathway to classify novel medical devices that provide a reasonable assurance of safety and effectiveness for the intended use and do not already have a predicate device on the market. FDA also declares that the devices marked as Class I or II as per De novo request can be further used as a predicate device for future premarket 510(k) notifications. De Novo Request Procedure There are two ways to submit a De Novo request to the FDA for a risk-based eval...
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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 MDR, General Information Cubicdesignz

The Role of Notified Bodies in Assessing Clinical Evaluation Reports (CERs) under EU MDR

Clinical evaluation is a continuous procedure that happens at every stage of a medical device’s life cycle. It is typically carried out initially in the course of developing a medical device to determine what data must be produced to gain access to the market. The first CE-marking must include a clinical evaluation, and it must be regularly updated going forward. Clinical evaluation is essential and significant because it guarantees that assessments of the device’s performance and sa...
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