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 agreements between a Private Label Manufacturer (PLM) and an Original Equipment Manufacturer (OEM). Although the IVDD...
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Giving Back
Nicolas Borenstein, DVM, Ph.D. Co-President, Preclinical Services “We are not a veterinary clinic and our primary mission is indeed to validate medical devices and novel therapeutic strategies in clinically relevant large animal preclinical models. However, it is...
Ten Things to Know Before You Start Your GLP Study
The most expensive study is one you have to repeat Good laboratory practice (GLP) studies are an essential component to medical product development and regulatory submissions. They are highly rigorous, are conducted in compliance with a legally bound code of federal...
Reducing the 90% Recurrence Rate for Glioblastoma Treatment Through an Implantable Device for the Delivery of Stem Cells
Extending Patient Lifespan with LifeSTEM What is Glioblastoma? Gliomas are brain tumors that come in multiple forms ranging from low-grade, benign tumors to high-grade, malignant tumors including glioblastomas. Glioblastoma treatment involves surgical resection,...
What Makes a Good Preclinical Study Final Report?
When it comes to meeting deadlines and continuing to receive investments, the timely review of your GLP preclinical final report is very important. Timelines are generally tight, and your report is not the only study that a reviewer* is working on. So, how do you...
How 3D Printing Can Accelerate Your Product Development Timeline
Accelerate Your Product Development Timeline 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 printing tools to design, test, and iterate more rapidly than we could if we...
The Ins and Outs of Using ECMO and VAD in Preclinical Studies
ECMO Vs. VAD Ventricular assist device (VAD) and extracorporeal membrane oxygenation (ECMO) are two similar temporary techniques to bridge cardiac therapy or transplants. In rare cases, they can also be a more permanent therapy for patients who are ineligible for...
Tackling Postpartum Hemorrhage: Innovations on the Horizon
Postpartum hemorrhage (PPH) remains a significant global health concern as the leading cause of maternal mortality worldwide. According to the World Health Organization (WHO), each year, about 14 million women experience PPH resulting in about 70,000 maternal deaths...
Exploring the Assay Development Pipeline for In-Vitro Diagnostics (IVDs)
Establishing a Strong Assay Foundation Before we can conceptualize IVD product configurations, we must establish assay inputs which include, but are not limited to: Identify the need for the test, e.g. diagnose breast cancer or sepsis, identify bacteria, monitor...