About Prepco Medical

Medical Component Engineering & Manufacturer

Prepco Medical, excels in tip forming, dilators, tube forming, and tipping die processes, with a certified team dedicated to translating your concepts into high-quality engineered prototypes for efficient medical component manufacturing.

Prepco: Your Medical Device Manufacturing Partner

Special Capabilities

Radio frequency (RF) induction end forming and welding of extrusion to net shape for catheter construction. We excel by end forming almost any engineering thermoplastic material to any size. We form extremely clean, crisp, and clear tips. We can even complete a full edge radius on a tip without any sharp edges, a process where experience shows.

We have perfected the ability to produce long, tapered tips with very soft materials. We have a unique ability to create smooth transition welds between different extrusions. To weld two different durometers, multi-lumen extrusions while keeping these lumens open is an accomplishment in our industry.

Pad printing with clear, strong images. We can put registration marks, graduations, and indicators in bands, or one to two side marks. Prepco Medical can print 30” images along an extrusion.

We provide high quality, yet low cost, hardened tool steel insert injection molds, particularly adept at specialty connectors and manifolds. Prepco Medical is capable of high-volume production, with single or multi-cavity molds. We can give you quotations within 24 hours.

All products that are shipped in bulk are placed in double polybags with cardboard shippers. Each bag is labeled with product number, revision level, lot number, quantity, purchase order number and description, and sterility condition.

Prepco Medical supplies certificates of compliance and a packing list with each shipment, turn around, and minimal set-up charges.

RF Induction Innovation for Precision Medical Device Manufacturing

Prepco Medical Manufacturing Facilities

With 7200 ft² of manufacturing space that includes 3000 ft² of ISO class 8 cleanrooms. The complex catheter and implant devices we manufacture adhere to comprehensive traceability and strictly enforced written procedures at each step of the manufacturing process.

The cleanrooms are fully equipped with injection molding machines, packaging, and custom forming & cutting equipment to meet your diverse manufacturing requirements.

Materials and quarantined items are stored in locked, controlled access areas. Both truck dock and raised platform shipping is available for receiving and shipping of small lots or large skids of product.

We operate with dedicated work cells for each medical device, combined with multi-use special operation areas for injection molding and bulk packaging. Cross-training is routinely used to provide flexibility in meeting quick delivery schedules.

Whether your product requires a work cell with one person part-time or a crew, we have the space and infrastructure to meet your production requirements. Options with flexible space in our building provide the expansion possibilities to meet required production needs.

Manufacturing Capabilities

Our ISO 13485:2016 Certified Team of engineers, material experts, skilled technicians, and Quality Assurance Specialists make Prepco Medical, stand out from the rest. You can count on us to develop functional prototypes and scale up for manufacturing. Prepco Medical offers you a true, full prototyping & manufacturing partnership with the resources to get your project into the market.

There are many medical device component manufacturers in the world but Prepco Medical offers decades of experience and a history of cost-saving innovations. Molding parts as small as .1 cubic millimeters is achieved with refined equipment and processes.

Prepco Medical offers a complete range of catheter manufacturing capabilities and the ability to create custom equipment allows us to produce complex, intricate devices to your specifications.

Our assemblers are experienced in very small medical device assembly often requiring processing and inspection under the microscope. We accept short run production testing as well as ongoing routine volume production shipped as desired.

Prepco Medical has 30+ years of contract medical component manufacturing specializing in minimally invasive, disposable surgical components.

We focus carefully on each aspect of manufacturing. Our exceptional product quality and success at solving complex manufacturing issues lead the industry.

What makes us stand out?

We focus carefully on each aspect of manufacturing, from concept discussions to final product testing. Our exceptional product quality and success at solving complex issues lead the industry.

Prepco Medical Manufacturing Capabilities

Your Partner in Catheter Processes with Expertise in Assembly and Clean Room Environments.

Prepco Medical Work Environment

We follow controlled work environment methods carefully, utilizing double door entry, entryway tacky mat floor coverings, protective garments and positive pressure HEPA filtered work areas. The work table surfaces are wiped daily with 70% isopropyl alcohol.

We conduct laser particulate air sampling and work surface viable particulate count.

Inspections of components and raw materials are conducted within HEPA filtered areas. Our Certificates and Authorizations

Prepco Medical strictly adheres to FDA Quality System Regulations. Products are manufactured according to CFR 820 regulations (Code of Federal Regulations, 21 CFR Ch. 1, part 820, Good Manufacturing Practice for Medical Devices, Subpart A-J.

Our Documentation and Quality Assurance Testing

The presence and identification of each component can be traced by its controlled lot number during the manufacturing process and in any and all shipments of completed devices. Prepco Medical maintains Device History Records, available for inspection at any time. Our quality assurance is serious business. All components and material inspections are conducted within HEPA-filtered laminar flow units meeting all federal standards which maintain clean room quality from manufacturing through testing.