Medical Contract Manufacturing

As an experienced medical device manufacturer, Keller Technology Corporation (KTC) has earned the trust of top organizations and companies in the extremely demanding healthcare, medical and life science industries.

With a huge wave of medical and technological innovation underway in the U.S. and abroad, KTC’s contract manufacturing services are an ideal solution for the medical device industry.

Why Medical Contract Manufacturing?

Medical equipment manufacturing requires strict adherence to federal regulations and quality standards in order to assure safe and reliable products. However, this can pose a challenge to the medical device industry due to the complexity of this compliance, the deep expertise required to fabricate these devices, and the qualified resources necessary to meet stringent regulatory controls.

Medical contract manufacturing companies like Keller Technology Corporation provide highly precise fabrication capabilities that meet all regulatory requirements for medical device manufacturing. At KTC, we are equipped to tackle medical device manufacturing and helping you design and engineer solutions that are optimized for performance while complying with all federal cGMP regulations.

As an ISO 13485 and 9001:2008 compliant medical equipment manufacturing partner, KTC offers specialized manufacturing services that meet your needs, alongside the level of experience you trust, so you can free up resources to tackle other business objectives.

Medical Contract Manufacturing in the U.S.

In the U.S., medical devices are universally used in everything from the most advanced health care surgical suites to your local pharmacy, with applications that range from consumer products to sophisticated diagnostic equipment. Regulated by the U.S. Food and Drug Administration, all medical devices sold in the U.S. are obligated to conform to the FDA’s three-tiered classification system, which requires varying levels of registration (including 510K filings), approvals, and quality controls. 

At Keller Technology Corporation, we build the equipment and assemblies to help support your medical device contract manufacturing process. We have the knowledge and experience necessary to comply with all cGMP regulations, and our manufacturing capabilities encompass all aspects of this quality critical, intensely regulated industry.

As an experienced medical contract manufacturer, KTC provides complex solutions to innovative companies in a variety of life sciences and medical industry sectors, including:

  • Radio-oncology
  • Imaging
  • Diagnostics
  • Pharmaceuticals
  • Medical robotics
  • Surgical equipment
  • And more

From design for manufacture to supply chain optimization to production and assembly, Keller Technology ensures your medical systems, equipment, and assemblies adhere to exacting standards.

Improve your time to market and ensure FDA compliance with the manufacturing capabilities of Keller Technology Corporation.

Complete Medical Contract Manufacturing Services

As a leading provider of contract manufacturing solutions for medical equipment and assemblies, Keller Technology offers the medical device industry a trusted, experienced partner in all phases of production:

  • Design and engineering support
  • Project management
  • Fabrication
  • Quality management systems (QMS)
  • Testing and calibration
  • Assembly

KTC can provide engineering support to augment your internal research and development efforts to help speed time to market.

During production, our manufacturing facilities and staff comply with current good manufacturing practices (cGMP), ensuring consistent quality controls from start to finish. We also provide assembly and documentation services to maintain the highest standards beyond the manufacturing process.

Contract Manufacturing Quality

An ISO 13485: 2016 certified contract manufacturer, KTC’s contract manufacturing services conform to stringent quality management standards, including medical device cleanroom manufacturing. Our processes include and verify stringent quality controls at all levels of design and production, so you can count on our QMS process documentation and ongoing dedication to quality.

We have extensive experience in high-level manufacturing, precision fabrication, cleanroom environments, and sophisticated diagnostics to meet all of our customers’ needs.

Your Medical Contract Manufacturing Partner

Keller Technology Corporation offers a combination of technological expertise, comprehensive engineering support, and cGMP-compliant manufacturing services to provide you with the best possible partnership for your contract manufacturing needs.

When you are looking for a medical equipment manufacturer you can trust, turn to one that is deeply experienced in medical device equipment and assemblies. KTC has the qualified team, as well as the technology, knowledge, expertise, and capability to help you manufacture your medical devices, diagnostics, and instruments.

From initial concept to final delivery, trust Keller Technology Corporation for your medical contract manufacturing needs.

To request a quote for your next project, contact us.

Contract Medical Manufacturing Project Profiles

contract manufacture guide

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