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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
FDA, USA Cubicdesignz Comments: 0

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 Comments: 0

FDA’s 510(K) Submission Process

The FDA 510(K) Pre-market notification submission as per 21 CFR 807 Subpart E is to be adopted by manufacturers to receive FDA clearance to market medical devices or for commercial distribution in the U.S. This review is done by FDA’s Centre for Devices and Radiological Health (CDRH). A 510(K) submission allows medical devices to be “FDA Cleared” and not FDA Approved. The route to 510(K) must be carefully investigated by the manufacturer through a step-by-step process which allows determin...
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12Jul 2024
FDA, USA Cubicdesignz Comments: 0

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, FDA, Regulations, USA Cubicdesignz Comments: 0

Cybersecurity for Medical Devices – FDA and EU MDR Perspective

FDA –Food and Drug Administration The revolution in the digital sector has resulted in the Internet of Things (IoT), Software as a Medical Device (SaMD), Internet of Medical Things (IoMT) and other connected devices permeating the healthcare environment, both in hospital and home, has ended up with the possibility of cyberattacks and intrusions against the connected medical devices and the networks to which such a device is connected. Most Medical devices are connected to the Internet, hospita...
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12Jul 2024
Canada, FDA, USA Cubicdesignz Comments: 0

eSTAR Pilot program by Health Canada & US FDA

eSTAR (electronic Submission Template and Resource) is an initiative launched by the US Food and Drug Administration in February 2020. It is a free, interactive PDF Form that provides assistance to the applicants in preparing the CDRH medical device submission for 510(k)s and De Novos. The content of the form is automated with an automatic verification feature, and the structure is complementary to the internal review and also harmonized with the IMDRF and guided construction for each submission...
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12Jul 2024
EU, Brazil, General Information, India, Swiss, UK, USA Cubicdesignz Comments: 0

Testing Standard Requirements around the World

Medical device testing standard- an overview Medical device testing is a crucial step in manufacturing a product. This mandatory process ensures that the medical device is safe and effective. Testing of medical devices proves that the product complies with the standards and regulations of a country. Moreover, it also sheds light on any product defects. This article discusses the testing requirements and the applicable standards. Medical device testing applies to all medical devices, in-vitro dia...
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05Feb 2024
EU, FDA, General Information, Regulations, Swiss, USA admin Comments: 0

Nomenclature of Medical Devices

Medical device nomenclatures are those products used to prevent, diagnose, treat, and monitor the many diseases known to humankind. Medical devices and medicines play an equally important role in treating human beings. To learn more about medical devices, read our article on the definition of a medical device. This article discusses the nomenclature of medical devices and examples of these. What is the Nomenclature of Medical Devices? To simply put it, the nomenclature is the naming of a me...
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05Feb 2024
EU, Brazil, FDA, General Information, IVD, Regulations, Swiss, UK, USA admin Comments: 0

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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Global Labelling Requirements
05Feb 2024
EU, Blogs, FDA, General Information, Regulations, UK, USA admin Comments: 0

Global Labelling Requirements

Label, Labelling vs Instructions for Use (IFU)? 1. A Label is the written, printed, or graphic information that goes on the packaging of the medical device. 2. Instructions For Use (IFUs) or Package Insert is the essential information accompanying the medical device for its safe and effective use by the user. It can be a single to multiple-page document. 3. Labelling is the content that goes on the Label or IFUs. What are the minimum requirements for labeling? The ISO has published many standard...
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