FEATURED EDITORIAL

This article examines the need to conduct clinical trials outside the U.S., addresses the recruitment crisis in the U.S., reviews the incentives for clinical trials overseas, and explores the growth of clinical trials in Latin America. Colombia is highlighted as a country that stands out as ripe with opportunity.
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European notified body feedback reveals that the biggest gaps in In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) submissions are being found in clinical evidence, particularly around clinical performance data. Also covered in this article is discussion of overlap between EU and FDA requirements.
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The digital revolution that resulted in the IoT, IoMT, SaMD, and connected devices comes with the possibility of cyberattacks. The FDA's latest efforts to enhance medical device cybersecurity include a new draft guidance (covered in this article) and bipartisan congressional support of the PATCH Act of 2022 (which will be covered in a future article).
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Amid continuing focus on environmental, social, and governance (ESG) priorities among investors across every industry, medtech companies need to begin revisiting business models and developing new sustainability strategies for competitive edge as well as regulatory compliance.
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How Early Raw Material Testing Mitigates Product Development & Regulatory Risk
Materials not subjected to early testing can contain impurities/contaminants that impact downstream biocompatibility issues, which can increase the risk of regulatory hurdles.
Non-contact sensing is invaluable in applications where measurements may be rendered unacceptably imprecise by slippage and poor speed management, or equipment or products may be damaged by contact.
Learn practical steps that help pharma contract outsourcers exercise greater control over their supplier-related data, interactions, and processes and put them in a better position to cope with supply continuity challenges as they arise.
Suppliers and manufacturers working together to improve quality throughout the supply chain creates high quality standards to ensure final products are safe and effective.
In the first part of the interview with Dr. Uwe Beekmann, Evonik looked at the biosynthetic cellulose, what it is, how it is made and potential applications. In this second part, submitted questions are addressed from the live interview session.
MED DEVICE ONLINE CONTENT COLLECTIONS

Artificial Intelligence and Machine Learning are taking the life sciences world by storm. Do you know how to harness its power for your medical device?Check out our latest e-bookwhich examines the opportunities AI and ML offer to both complement and supplement human intelligence in the medical device industry.
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