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Access to De Novo Summaries – A treasure for manufacturers

The De Novo pathway by the US Food and Drug Administration (FDA), is a risk-based classification process to classify novel medical devices for which there are no legally marketed predicate devices. It is one of the least used pathways by medical device manufacturers when bringing a product to market because of the associated data requirements,…

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CLIA Database: A Centralized Database of Clinical Tests & Instruments

Diagnosis plays a vital role in curing a disease. If the diagnosis itself is wrong, the disease cannot be treated. Osteosarcoma, a dangerous but common form of bone cancer which mostly affects the population of children and young adults (15 – 24), is often being misdiagnosed as growing pains or muscle strains, according to the…

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De Novo paving the path for Technological Advancements

While there existed many computerized and digital tomographs with specific applications (Trauma CT, Cardiac CT, CT used in Nuclear Medicine / PET), there has never been one with an application in the respiratory space. Electrical impedance tomography (EIT) is a noninvasive, non-radiologic imaging modality that is useful for the assessment of lung disorders during mechanical…

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The Harmonized ISO 13485 – A Brief Insight!

Can you imagine using life-saving medical devices that have not been certified for quality, safety and efficacy? These aspects if compromised, can result in enormous adverse effects and are simply non-negotiable! Let’s take a look at how one can prove their devices to be safe and effective and ensure high quality throughout its life.  ISO…

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Quality Sytems: Facilitating continuous improvement!

What is continuous improvement and how can we achieve it? An answer to this is a premeditated and well-implemented quality management system (QMS). A QMS, in simple words, is a system in which documents on various processes, relevant to the medical device or activities around it, are maintained. This does not mean that QMS is…

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IEC 60601-1 Evolution of Electrical Safety standards to match Device Development

Standards are considered an integral part of product design & development. Standards are very important in medical device applications. Some of the most critical standards exist in the medical device industry for ensuring the electrical safety of devices. Millions of electronic devices that produce electricity or work on it, rely on IEC (International Electrotechnical Commission)…

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Document Control System: The Core of Quality Management System

Has managing documents always been a tedious and time consuming task for you? Have you faced issues of cost drain and compliance while maintaining the documents for medical devices?  We understand! read below to learn about some document control systems that can help make almost any business more efficient. Due to the very nature of…

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FDA – Medical Devices Advisory Committee

The U.S. Food and Drug Administration (FDA) has 31 advisory committees responsible for the evaluation and regulation of drugs, medical devices, and biologics. The advisory committee protects and promotes public health while meeting the requirements established in the Federal Advisory Committee Act. Committees are either mandated by statute or established at the discretion of the…

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Industrial port and container yard
IMPORT/EXPORT-U S: Expand your boundaries

Globalization and international trade has drastically changed the face of the world. In the last couple of years, communication and trade has bloomed between the developed and developing countries. The  wave of globalization, in the healthcare domain, has resulted in  a  surge of import and export of medical devices to various parts of the world…

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