By Sophia Puliasis

Sex Differences in Clinical Trial Recruiting

Biostatistics, Clinical Trials, Med-Tech & Medical Device, Pharma & Drug Development, Uncategorized
The following article investigates several systematic reviews into sex and gender representation in individual clinical trial patient populations. In these studies sex ratios are assessed and evaluated by various factors such as clinical trial phase, disease type under investigation and disease burden in the population. Sex differences in the reporting of safety and efficacy outcomes are also investigated. In many…
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By Sarah Baker

Medical Device Categorisation, Classification and Regulation in the United Kingdom

Clinical Trials, Med-Tech & Medical Device
Contributor: Sana Shaikh In this article Overview of medical device categorisations and classifications for regulatory purposes in the United Kingdom Summary of medical devices categorisations based on type, usage and risk potential during use as specified in the MDR and IVDR. The class of medical device and its purpose determines the criteria required to meet regulatory approval. All medical devices…
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By James Des-Rosiers

Regulation of Connected Medical Devices and IOmT

Clinical Trials, Med-Tech & Medical Device
Collection and transmission of personal biologic and health information via IOmT connected medical devices requires regulatory oversight and has cybersecurity implications. Connected medical devices (CMDs) can produce and transmitting patient data, allowing their condition to be monitored by healthcare professionals. They are often used in decentralised clinical trials (DCTs) outside of the clinical trial site, allowing for participants who wouldn’t…
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By James Des-Rosiers

Cybersecurity Considerations for Connected Medical Devices and the “Internet of Medical Things”

Med-Tech & Medical Device
Cybersecurity for IOmT connected medical devices. Advancements in technology of the past few decades has led to the development of devices capable of connecting to one another via networks such as Wi-Fi and Bluetooth, allowing them to create, transmit and receive data between one another. Medical technology (Medtech) companies have utilised these features to develop connected medical devices. These devices…
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By Sabine Dreibe

Medical Device Clinical Trials vs Pharmaceutical Clinical Trials – What’s the Difference?

Clinical Trials, Med-Tech & Medical Device, Pharma & Drug Development
Medical devices and drugs share the same goal - to safely improve the health of patients. Despite this, substantial differences can be observed between the two. Principally, drugs interact with biochemical pathways in human bodies while medical devices can encompass a wide range of different actions and reactions, for example, heat, radiation (Taylor and Iglesias, 2009). Additionally, medical devices encompass…
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