In-Vitro Diagnostics
Precision components for accurate diagnostics
In-vitro diagnostic (IVD) customers often face pressure to ensure precision, sterility, and scalability while keeping up with evolving regulatory demands.
For over two decades, Freudenberg Medical has been a trusted partner in the development and high-volume manufacturing of intricate IVD components. Our annual delivery of over 80 million custom-molded thermoplastic and silicone parts to in vitro diagnostic OEMs illustrates our unwavering commitment to precision and scale.
Innovative IVD Solutions
We provide customers with innovative, high-quality solutions developed through efficient, multiphase processes that help streamline production timelines. By applying lean manufacturing principles, we work to reduce waste and continuously refine our processes. We aim to meet your evolving needs with precision and care.
From rapid prototyping and DFM support to full-scale production, we adopt lean manufacturing principles throughout the organization, offering a wide range of capabilities tailored to enhance your competitive edge.
Discover our Lean Manufacturing
Our expertise spans advanced thermoplastic and silicone injection molding (including LIM, multi-component, insert overmolding, and micro molding), along with scalable assembly for IVD devices and cartridges.
Discover our Molding Capabilities
IVD Product Development
Our experienced team possess the technical resources in-house to solve a range of manufacturing challenges.
We have proven expertise in the development and manufacture of IVD products such as lateral flow products, molded assay components, and microfluidic and fluidic chips. Our capabilities extend to filling and sealing processes, as well as the development of components for hematology, immunoassay, urinalysis, clinical chemistry, microbiology, oncology, and molecular diagnostics. We serve both laboratory-based systems and point-of-care (POC) platforms, including rapid diagnostic tests, home sample collection kits, and patient self-monitoring systems.
Additional expertise includes drug delivery devices, diagnostic test kits, consumables, fluid management tube sets, and components for laboratory and PDC applications.
To support every stage of your project, we also offer value-added services such as:
laser etching
pad printing
sterilization management
labeling
fully automated packaging
All designed to deliver consistent quality and peace of mind.
Trusted Partner for Ivd mANUFACTURING
Backed by Freudenberg Group’s global R&D centers, we offer simulation and analytical services such as structural mechanics, FEA, flow simulation, and testing. Our comprehensive technology stack includes advanced automation, full metrology labs, proven validation protocols, and a dedicated engineering team focused on delivering high-quality, timely solutions for your diagnostic needs.
We support the IVD market with a truly global footprint. This includes two facilities in Southern California, right in the heart of the IVD ecosystem:
