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Don't ask "Can this model work?" Ask "Is this the optimal preclinical model for regulatory success?" When your breakthrough, truly novel or generational new medical device idea transforms from napkin sketch to regulatory submission, one critical...
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Behind many successful medical devices are design and engineering firms that provide the technical expertise, regulatory knowledge, and development...
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The Art of the Specific Question for FDA Pre-Submission Guidance and Human Factors FDA pre-submission meetings (aka Q-Sub meetings) represent...
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Institutions and enterprises around the world are pushing the boundaries of medical innovation by applying advanced robotic technologies to address...
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The investigational model considered the use of the EXENT® GAM Assay from the Binding Site, part of Thermo Fisher Scientific. This is a mass...
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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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Assembling a team for an efficient preclinical study When it comes to kicking off your preclinical study, assembling the right team will help you...
