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Medical Device

Regulatory Framework for Software and Artificial Intelligence as Medical Device

Blogs, Medical Device, Regulatory /

The convergence of healthcare with technology has led to giant innovations, one of the most significant being the use of software and artificial intelligence (AI) as medical devices. Such developments have been called Software as a Medical Device (SaMD) by many and have wide applicability in transforming the diagnosis, treatment, and care of patients medically. […]

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Specifications for In Vitro Diagnostic Devices

Blogs, Medical Device, Regulatory /

In vitro diagnostic medical devices (IVD devices) are an integral part of the healthcare system. They are typically used to analyze samples that are collected from the human body (i.e., saliva, blood, tissue, and urine) and help in diagnosing, screening, and monitoring various conditions. IVD devices are subjected to different regulations that specify different requirements

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The Use of EDDO to Ensure Drug Delivery Function

Blogs, Medical Device, Regulatory /

When it comes to ensuring the safety and effectiveness of medical devices intended to deliver drugs, understanding Essential Drug Delivery Outputs (EDDOs) is important. The advent of drug-device combination products has necessitated the development of robust guidelines to ensure safety, efficacy, and performance. One such crucial aspect of these combination products is the Essential Drug

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Ensuring Transparency for Machine Learning-Enabled Medical Devices

Blogs, Medical Device /

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

Blogs, Clinical Regulatory, Medical Device, Regulatory /

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?

Blogs, Medical Device, Regulatory /

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

Blogs, Medical Device, Regulatory /

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

Blogs, Clinical Regulatory, Medical Device, Regulatory /

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

Blogs, Medical Device, Regulatory /

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

Blogs, Medical Device /

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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