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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 must-ask questions for medtech companies in the market for a preclinical CRO. Are you GLP compliant...
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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
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When it comes to meeting deadlines and continuing to receive investments, the timely review of your GLP preclinical final report is very important....
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One of the biggest timeline impacts in any development program is getting the product to work. Our engineers and designers utilize our in-house 3D...
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Ventricular assist device (VAD) and extracorporeal membrane oxygenation (ECMO) are two similar temporary techniques to bridge cardiac therapy or...
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When a medical product innovator has reached the point at which preclinical research is necessary to achieve the next milestone, they have already...
