Switzerland has officially implemented its adapted Ordinance on In Vitro Diagnostic Medical Devices (ODiV), effective January 1, 2025. This strategic alignment ensures regulatory equivalence with EU IVD regulations (2017/746 EC, IVDR) while providing manufacturers...
Testing Medical Devices with Artificial Anatomy Models
Whether you’re a new medtech startups or established strategic, testing new devices against realistic anatomical conditions is crucial for success. Artificial anatomy models for medical device testing offer a practical, cost-effective solution that addresses many...
Five Questions to Ask When Selecting a CRO for Preclinical Studies
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 CRO that can perform preclinical studies Are you GLP...
Optimizing PLM-OEM Collaborations: Key Strategies for a Smooth IVDR Transition
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...