FEATURED EDITORIAL
This article dispels the myth that obtaining EU MDR certification is an end point. The evolving landscape demands ongoing diligence to comprehend and adhere to changing requirements.
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Deploying a formal system for regulatory information management is a given now for all life sciences companies, irrespective of their size and focus. Regulators expect this, particularly as data rather than static documents evolves to become the default.
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The proposed FDA regulation for laboratory developed tests marks a significant step toward the FDA trying to standardize oversight for these diagnostic tools. As the FDA seeks public input, it is a hot topic as stakeholders grapple with the implications of increased regulatory scrutiny, debating its impact on patient access, innovation, and the overall landscape of diagnostic testing in the U.S.
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With the recent publication of the European Union’s long-awaited Artificial Intelligence Act (AI Act), the message to medtech companies is clear: you need to move toward compliance by understanding your AI systems, determining their role under the AI Act, and identifying the specific obligations and implementation strategies that apply.
INDUSTRY INSIGHTS
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The Impact Of 3D Printing On Micro Molding — A Synergistic Approach
Explore the future of micro manufacturing, where the convergence of micro molding and 3D printing promises to redefine what's possible in the creation of intricate, high-quality components.
Explore how medical imaging technology advancements enhance diagnostics and patient care, focusing on hybrid imaging modalities, system performance, and portability design.
Cardinal Health's Jorge Sahlieh discusses his role at Cardinal Health, the international business, and the challenges and trends he sees shaping the healthcare industry.
Fourier Transform Infrared Spectroscopy (FT-IR) is a reliable method with multiple applications when it comes to identifying both intrinsic and extrinsic compounds in a drug product.
Discover RFID's advantages in medical devices, guidance for supplier selection, and success stories from healthcare's RFID integration, offering valuable insights and practical examples.
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-book which examines the opportunities AI and ML offer to both complement and supplement human intelligence in the medical device industry.
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