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Medical Device

MHRA’s AI-Airlock for Safe Development of Medical Technologies

The use of artificial intelligence (AI) in the Pharmaceutical and Health Care industries has paved the way for more innovative opportunities to help enhance patient outcomes. This is with respect to the diagnosis, treatment, and overall personalized patient care. However, as these technologies evolve, so do the challenges especially when it comes to testing these …

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Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices

As more artificial intelligence (AI) and machine learning (ML) technologies become increasingly available, the uniqueness of medical devices also evolve. Though AI/ML-driven devices provide support for diagnosing and treating more complex conditions, their unique features highlight the need for a more harmonized approach towards device regulation for patient safety. Regulators across the globe are gradually …

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AMDF: Ensuring the Safety of Donated Medical Devices

In times of emergencies like war, disease outbreak, natural disasters etc that lead to a rise in casualties, humanitarian support such as donations may be required. These donations can range from basic items like clothing to more technical complex items such as medical devices. While donations can be crucial during emergencies, they also bring challenges …

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Ensuring Safe Use of Medical Devices in Healthcare Facilities

The safe and effective use of medical devices in healthcare facilities is not merely a matter of convenience; it is a moral obligation. The welfare of patients and the quality of healthcare services depend on the responsible use of these devices. Accidents involving medical devices can have dire consequences for patients. These accidents may result …

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Drug Device Products

Drug-Device Products: Navigating through the EU

Drug-device combination (DDC) products are increasingly demonstrating the value they bring in diagnosing, treating, and curing complex diseases. The growth of the DDC market is driven by several factors including an increase in chronic diseases, a well-established medical technology industry, a rise in surgical procedures, the availability of funding for research and innovation etc. As …

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Digital Health Technology

Challenges With Medical Devices and Digital Health Technologies

Currently, there are over 2 million diverse types of medical devices accessible in the global market, which are further classified into more than 7000 generic device groups. As of 2021, the worldwide medical devices market was valued at USD 488.98 billion and is predicted to grow at a compound annual growth rate (CAGR) of 5.5% …

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Digital Future of Healthcare

Digital Future of Healthcare

Introduction The COVID-19 pandemic and changes in legal frameworks have sparked and accelerated the major trend of digitalization in the health sector. This trend is expected to result in merging digital products, including medicinal products and medical devices, into a digital ecosystem supported by shorter development cycles and technological progress. Digitalization is expected to improve …

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Artificial Intelligence

Regulatory Guidelines for Software and Artificial Intelligence as a Medical Device

Technological disruptors are gradually revolutionizing various aspects of life sciences and healthcare. Software is slowly becoming an important part of products and are being integrated into digital platforms for medical and non-medical purposes. There are 3 types of software-related medical devices: 1) Software as a medical device (SaMD), 2) software in a medical device, and …

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Healthcare Sector

Rise of Digital Applications in the Healthcare Sector

The healthcare sector has been significantly impacted by technology, with the rapid growth of digital health applications projected to continue due to increased demand for remote healthcare services, especially during the COVID-19 pandemic [1]. According to the US FDA, software-based medical devices are increasingly being used for diagnosing, treating, and monitoring complex diseases. The adoption …

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Combination Products

Combination products: a regulatory perspective

Combination products are an integral part of healthcare as they provide innovative treatment options for complex diseases. They can be as simple as a first aid kit with vials & syringes or as complex as antibody-drug conjugates combined with drugs [1]. More often the development of combination products helps to enhance the function of an …

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