From Initial Concept to Finished Product
ReCathCo’s goal is to earn your satisfaction by providing catheters of unparalleled quality and outstanding performance. To do that, we share our knowledge and experience in catheter design and manufacture to leverage our state-of-the-art production facilities to your maximum benefit. Whether providing consultation for a research trial or meeting your specifications for an approved device, ReCathCo’s goal is to develop efficient solutions for your catheter projects, while meeting your delivery demands, and accommodating your budgetary expectations.
Vertically Integrated Processes for Optimal Quality Control
To ensure continuous quality between production processes, every step of ReCathCo’s ISO Compliant design/production process is performed within our headquarters facility, including:
- Initial Product Assessment
- Device Design Consultation
- Computer Aided Design Materials Specification Prototype Development Polymer Compounding Tubing Extrusion Statistical Process Controls Device Assembly
- Joint Welding
- Weld-Strength Tensile Testing Polymer-Embedded Color-Striping Micro-Printing Micro-scale-Length Indication Open-End Tip Forming Closed-End Tip Forming
- Precision Shearing
- Product Inspection
- Product Packaging
- EtO Package Sterilization
Our commitment to your satisfaction begins with our ISO-Compliant, vertically integrated, catheter design and manufacturing process. Our production facilities are housed under one roof within in our 8,500 square foot headquarters building located in Allison Park, PA. To assure you of our commitment to quality, ReCathCo employs ISO-compliant practices throughout the quality manufacturing processes shown below.
ISO Compliant for Animal Research and Medical Devices
In keeping with our goal of continuous improvement in product excellence and constant attention to customer care, ReCathCo is compliant with ISO 13485:2003 as a Contract Manufacturer of Catheters and Extruded Tubing for Research and Medical Devices.
One-Roof Production for Customer Satisfaction
Because we work closely with our customers to effectively design and efficiently manufacture their catheter products, every step of ReCathCo’s manufacturing process is performed under one roof within our environment- friendly facility. Locating our four clean rooms adjacent to our administrative offices ensures fast turnaround on early-stage revisions as well as on-the-fly quality control during large-scale production runs.
Clean-Room Manufacturing for Consistent Product Quality
To ensure optimal quality control over production processes, all ReCathCo tubing and catheters are manufactured and assembled within our four clean-rooms.
USP Class VI Materials Throughout
In keeping with our goal of ensuring both outstanding performance and optimal bio-compatibility, in both research and medical applications, all materials used in ReCathCo products meet USP Class VI Materials standards for consistency, quality, purity and strength.
Micro-Scale Extrusion for Exacting Precision
To ensure that ReCathCo products meet our customers’ expectation of precision, our state-of-the-art manufacturing facility is dedicated to achieving exacting tolerances in both materials and metrics. Our custom-configured micro- scale, single and dual-feed, statistical process controlled extrusion lines produce polymer tubing as fine as 32 gauge (0.010 inches). For especially demanding applications micro-scale tubing can be ultrasonically tuned to exacting 2- axis tolerances. Such precision results in near-perfect dimensional trueness for inside and outside diameters as well as for tube wall thickness. ReCathCo’s fine dimensional tolerances ensure joint-fit exactness during assembly as well as device durability while under mechanical strain in actual use.
Biological, Chemical and Materials Compatibility-Matching for Robust Performance
Superior catheter performance necessitates understanding the biological compatibility, chemical reactivity and materials performance characteristics of different catheter components. To ensure optimal service ReCathCo employs its long experience in catheter production to match your project objectives with device design, materials selection, component bonding demands and in-service durability.