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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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12Jul 2024
EU, Regulations Cubicdesignz

The ‘Blue Guide’ on EU product rules implementation 2022 

The amended ‘Blue Guide’ on the application of the product rules 2022’ (“Blue Guide”) was released by the European Commission on June 29, 2022. The Blue Guide allows a better understanding of EU product regulations and their uniform and coherent application across various sectors throughout the EU single market. The Blue Guide has undergone significant changes, including the definition of new terms, the addition of information on which economic actors will be responsible for compliance...
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12Jul 2024
EU, News, Regulations Cubicdesignz

Risk Management of medical devices under MDR

All medical devices are associated with inherent risks of some level. It is imperative to understand the medical device’s specific risks to a patient. Under EU MDR 2017/745, risk management is a continuous and iterative process. Manufacturers are expected to plan, document, and implement risk management strategies in this process. These strategies may either eliminate the risk or mitigate the overall severity of the risk. Medical Device Risk- Definition      ...
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12Jul 2024
EU, Regulations Cubicdesignz

Cybersecurity for medical devices in Europe

EU Cybersecurity laws for Medical devices are advancing, and the use of software medical devices is also increasing daily. The increased interconnection of medical devices to computer networks and technological convergence have made devices and software programmes vulnerable to mishaps. The importance of protecting patient data from cyber-attacks is now well recognised. With the advancement of software as a medical device, proper regulations must be established to ensure the safety and security...
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12Jul 2024
Blogs, EU, Regulations Cubicdesignz

EU MDR – Language Requirements  

October 2021.   The EU MDR 2017/745 brings more safety to the device in the European market. As part of the Safety measure for the largest medical device market in the world EU Union has made measures to make sure the product sold in the EU market is accessible for everyone at the same time is safe and traceable at every stage of the product lifecycle. The new regulation has made measure that a professional user as well as a lay person can understand the correct usage of the devic...
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12Jul 2024
EU, Regulations Cubicdesignz

In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746

The IVD medical devices Regulation (EU) 2017/746 (IVDR) brings EU legislation into line with technical advances, changes in medical science, and progress in law-making. The new Regulation creates a robust, transparent, and sustainable regulatory framework recognised internationally, improving clinical safety and creating fair market access for manufacturers.  In contrast to the previous Directive, the new Regulation is directly applicable and does not need to be transposed into na...
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