Manufacturing

Our extensive manufacturing capabilities include engineering services, converting, and final assembly. Katecho can help manage all aspects of your project — from the initial idea to an approved design, from a single product to mass production, from the building blocks of a product to the product itself — and every step in between.

With state-of-the-art medical device manufacturing facilities, experienced professionals at every level, and the passion of building innovation for life, we can turn your idea into a reality. Contact us today to explore the virtually endless possibilities Katecho has to offer in medical contract manufacturing.

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Engineering

Overview

Engineering serves as the liaison between our customers and Katecho. Our business model of being a contract manufacturer means that we build our customers’ products — and that we don’t compete with them. Every product we manufacture for our customers is their property, so you can count on our full partnership and absolute confidentiality in regard to your projects.

Project

The project phase refers to the period of time prior to a new product launch. Katecho has a dedicated engineering staff that establishes and qualifies the process for manufacturing your new product.

Product

The product phase refers to the period of time after a new product has been launched. We have another dedicated engineering staff that controls the process, manages the lifecycle of the product, and strives to improve product quality and lower production costs.

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Converting

Capabilities

At Katecho, we offer laminating, slitting, and rotary die-cutting for both island placement and snap placement. We’re happy to final-assemble your products for you, or provide subassemblies so you can construct the finished goods at your facility.

Quantities

We can produce products in low quantities cost-effectively by using low-cost dies. We also have equipment that can handle high-volume quantities quickly and with precision.

Quality

Our servo-controlled equipment ensures high-speed precision, while our vision systems enhance accuracy. We have auto-splice detection as well as auto-reject systems that take nonconforming materials out of production.

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Assembling

Quantities

We can build your final product in virtually any volume — from one to 100 million — by hand assembly or full automation. And we can even kit, package, and ship your product for you.

Quality

Katecho has a controlled-environment room on site in which we can build products with minimal exposure to bio-burdens. We make Class 1, 2, and 3 medical devices and offer sterile capabilities through one of our trusted partners.

Certifications

We comply with Part 820 of the FDA, as well as 21 CFR Quality Systems Regulations. We’re also ISO 13485-certified, MHLW-certified (Japanese Ministry of Health, Labor and Welfare) and CMDR-compliant (Canadian Medical Device Regulations).

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