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Your Trusted Manufacturing Partner for IVD Components

Experts in Diagnostics

For over two decades, Freudenberg Medical has partnered with customers around the world to develop and manufacture highly complex IVD components - at high volume. We supply over 80 million custom molded thermoplastic and silicone parts per year to in vitro diagnostic OEMs. 

As a global CMO with 11 manufacturing operations and more than 2,500 associates worldwide, our network team of engineers can work with you at every stage of the product lifecycle. We work on projects that range in complexity with various precise molding and tight tolerance requirements. We know what it takes to ensure critical diagnostic equipment performs optimally with flawless execution, and we love solving problems that no-one else can.

Leaders in IVD Manufacturing

Our experienced team of experts possess the technical resources in-house to solve a range of manufacturing challenges. Freudenberg Medical has proven expertise in the development and manufacture of IVD products such as lateral flow components, diagnostic cartridges, point of care devices, and PCR test kits used in a variety of applications.

Specialized IVD Manufacturing Capabilities

We create innovative, high quality, robust, safe and effective solutions that combine multiphase processes, which reduce time in production. Lean principles drive our manufacturing methodology, ensuring waste is minimized and processes are continually reviewed and optimized. Using advanced tool design and visual inspection systems, we meet customer expectations every time.

Whether you require development of a rapid prototype or wish to optimize an existing process, we offer a wide range of manufacturing capabilities to give our partners a competitive edge.

  • Product development support, design for manufacturability (DFM).
  • Advanced thermoplastic injection molding and assembly: leaders in various molding processes including thermoplastic injection, silicone (LIM), multi-component (two shot), insert. over molding, and micro molding.
  • Assembly: sub or full assembly of IVD devices and cartridges with automated scaling capabilities.
  • Value-added services: laser etching, pad printing, sterilization management, labeling, and fully-automated custom packaging.

Why Choose Freudenberg Medical?

Driven by a passion for innovation, the engineering teams at Freudenberg Medical use cutting edge tools from product prototyping to molding, serial manufacturing, and assembly.

We are problem solvers. We have the technology including advanced automation, a full metrology lab, proven validation processes, and a dedicated engineering team to ensure delivery. We can provide scalable, high-volume production to ensure peace of mind for our customers, with reliability and security of supply.

At Freudenberg Medical we are proud of the transparency we offer our customers. We know how critical it is to deliver on time and with zero defects - we never make promises we can’t keep. Freudenberg cares about your products, your customers, and our partnership.

0 custom molded thermoplastic and silicone parts per year manufactured for IVD OEMs around the world

Collaboration

Our team uses a multi-phase process to deliver products to customers. This proven approach helps structure the flow of product development and ensures maximum collaboration at every step. We communicate frequently with our customers, provide consistent and timely production schedules, and thoroughly document each development process.

We adopt lean manufacturing principles throughout the entire organization from the compilation and development of customer requirements to the completion of a finished product with zero defects.

 

Customer Focus

Our customer centric manufacturing processes ensure that needs and expectations are explicitly documented, translated into requirements and manufacturing transfer project plans are executed on-time and within budget, from a single product line to a full facility transfer.

We work alongside customers to define processes and procedures that reduce lead time, create a balanced workflow, and meet demand on time while achieving exceptional quality.

Unique Insights

Freudenberg Medical has local operations in all the major medical device clusters worldwide including two operations in Southern California in the heart of the IVD market. In addition, we have valuable access to a global R&D support network through Freudenberg Group R&D centers worldwide for simulation and analytical services including structural mechanics, FEA, flow and process simulation, and testing.

We have an unrivaled technology stack including advanced automation, a full metrology lab, proven validation processes, and a dedicated engineering team to ensure prompt and accurate delivery.

 

Stability

We are financially stable, privately owned and backed by the 175-year-old Freudenberg Group. Freudenberg Medical is not at risk of exposure to the M&A activity so prevalent in the industry. We have a long term vision to continue our growth in this sector. We have eleven ISO 13485 certified facilities worldwide with most operations now FDA-registered.

Our 72,000 square foot Baldwin Park, California, site enables medical component manufacturing at scale, developing and deploying global scope programs for many of the top names in the medical device field.

Areas we serve

  • Lateral flow products 
  • Molded cartridges / assay components
  • Fluidic and microfluidic chips 
  • Filling and sealing 
  • Hematology analyzers 
  • Immunoassay analyzers 
  • Urinalysis 
  • Clinical chemistry analyzers 
  • Microbiology 
  • Hematology 
  • Home sample collection kits 
  • Infectious disease 
  • In vitro diagnostic consumables 
  • POC in vitro diagnostic tests 
  • Microfluidic cartridges 
  • Oncology 
  • PDC
  • Rapid diagnostic tests 
  • Point of care analyzers 
  • Drug delivery devices 
  • Immunoassay 
  • Molecular diagnostics spectrum
  • Fluid management tube sets 
  • Laboratory components for immuno and clinical chemistry assays 
  • Patient self-monitoring systems and components 
  • Diagnostic test kits and consumables

Your Contract Manufacturing Partner

We work closely with customers to better understand your specific needs and how we can integrate successfully with your production and manufacturing roadmap. Freudenberg Medical is a full-service, one-stop source for IVD component fabrication.

 

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