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When a clinical trial faces data quality challenges, every day counts. Rescue studies have become an increasingly critical component in preserving valuable research and protecting investments in medical device development. But what exactly...
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As artificial intelligence transforms healthcare innovation, the FDA continues to evolve its regulatory framework for AI-enabled device software...
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Switzerland has officially implemented its adapted Ordinance on In Vitro Diagnostic Medical Devices (ODiV), effective January 1, 2025. This strategic...
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Whether you’re a new medtech startups or established strategic, testing new devices against realistic anatomical conditions is crucial for success....
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Medical device innovators need trustworthy CROs for preclinical studies to help speed the process from concept to commercialization. Below are a few...
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Under Directive 98/69/EC (IVDD), it was common practice for in vitro diagnostic medical devices to be placed on the European market under contractual...
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How do regulatory requirements within the medical device industry impact a database build? What are the important items to be aware of? In this blog,...
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Nicolas Borenstein, DVM, Ph.D. Co-President, Preclinical Services “We are not a veterinary clinic and our primary mission is indeed to validate...
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The most expensive study is one you have to repeat Good laboratory practice (GLP) studies are an essential component to medical product development...
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Extending Patient Lifespan with LifeSTEM
