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Machine Learning-Enabled Medical Devices

Ensuring Transparency for Machine Learning-Enabled Medical Devices

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Transparency in Machine Learning-Enabled Medical Devices (MLMDs) refers to the degree to which relevant information about a device—such as its intended use, the development process, performance, and logic—is clearly communicated to stakeholders.  Why is this important? To help the development of safe, effective, and high-quality AI/ML learning technologies. These may learn from real-world data and […]

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Clinical Evaluation of Orphan Medical Devices

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In the European Union, the Medical Device Coordination Group (MDCG) continues to address unique challenges in the medical field, by bringing life-changing orphan medical devices to patients who suffer from rare conditions. These devices that are intended for a small number of individuals are subject to various hurdles in their development and market introduction. The

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How is Team AB Gearing up for the new MedTech Legislation?

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In the development of the UK’s medical device industry, a consortium of Approved Bodies (AB) united under the banner of the UK Association for Medical Device Approved Bodies, or simply, Team-AB. This coalition marks a landmark as these bodies converge to advocate for cohesive regulations in the evolving landscape of medical device oversight. The genesis

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Regulatory Roadmap for Access to MedTech

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In an era driven by technological advancements, particularly in healthcare, the need to implement a robust regulatory framework is more than ever to ensure compliance and patient safety. Indeed technological disruptors such as implantable medical devices, artificial intelligence, software, and diagnostics play a crucial role in healthcare whether they facilitate early detection or prevent complex

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Streamlining Clinical Investigations for Medical Devices

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Clinical investigations for medicinal devices are critical in order to advance healthcare and patient safety. Streamlining clinical investigations help accelerate the delivery of innovative solutions to patients, which ensures timely access to devices that would help diagnose and treat diseases. Simplifying regulatory processes, enhancing stakeholder engagement, and aligning with global practices fosters more rapid approvals.

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Third Party Review Program for Medical Devices

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The onset of the pandemic highlighted many obstacles pertaining to medical devices used to detect and diagnose the virus, SARS-CoV-2. Many device manufacturers emerged with their concerns and requested for “Emergency-Use Authorization” (EUA) for their in vitro diagnostic medical devices used to help detect the virus. In response to this request, the US FDA provided

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Enhancing Medical Device Cybersecurity

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The integration of wireless, Internet, and network-connected capabilities in medical devices, coupled with the frequent exchange of health information, necessitates robust cybersecurity controls. A cybersecurity threat can compromise the safety and/or effectiveness of a device by compromising the functionality of any asset in the system if there is an absence of adequate cybersecurity control. Regulatory

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Utilizing Real-World Evidence for Medical Devices

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Recent years have witnessed a surge in clinical practice data generation outside of trials, driven by advanced signal detection technologies and expanded database capabilities. The integration of real-world data (RWD) with artificial intelligence (AI) tools is reshaping regulatory and medical decision-making. Various user-generated practice data types are stored in centralized databases, offering valuable longitudinal observations

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ANVISA & ANMAT: Mutual Recognition Agreement for Medical Devices

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The medical device sector in Argentina and Brazil is experiencing robust growth and development to keep up with the demand in more comprehensive options to diagnose, prevent, and treat complicated conditions. Indeed, rising healthcare demands and an increase in the awareness of advanced medical technologies propel a surge in the adoption of innovative devices. Coupled

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

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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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