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...
Training: ISO 14155:2020 Clinical Investigation of Medical Devices for Human Subjects — Good Clinical Practice
Speaker Jérôme Randall, PhD Scientific Affairs Manager Date March 11th & 13th 2025, Online Duration 6 hours | 2 x 9:00 – 12:00 AM US Eastern Standard Time, 2 x 3:00 – 6:00 PM Central Europe Time Virtual A recording will be available to registered participants, in...
Training: EU General Data Protection Regulation (EU GDPR)
Speaker Elena Lucano, PhD, Senior Manager, Quality and Regulatory Affairs Date March 20th 2025, Online Duration 4 hours | 8:00 – 12:00 AM US Eastern Standard Time, 2:00 - 6:00 PM Central Europe Time Virtual A recording will be available to registered participants,...
Training: Basic Biocompatibility Practical Perspective & Regulatory Aspects
Speakers Monica Grekula & Lina Burman Date April 8th & 11th 2025, Online Duration 6 hours | 2 x 8:00 – 11:00 AM US Eastern Daylight Time, 2x 2:00 – 5:00 PM Central Europe Summer Time Virtual A recording will be available to registered participants, in case...
Challenges for Medical Device Database Builds
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, we will look at these and other questions, with a focus on the data management/database build work within medical...
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...