Independently Verified • Updated

The Top 10 Medical Device Manufacturers Providers in 2026

The leading medical device manufacturers

Editor Researcher
Expert Editorial Team Parker Davis

About Top medical device manufacturers

Empowering informed decisions in healthcare by providing transparent rankings and reviews of medical device manufacturers for quality service and patient safety.

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#1
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Katecho

Des Moine, IA

4.9 Editorial Score
Verified Community Trusted $$$

Katecho, LLC is a dynamic presence in the field of medical contract manufacturing, with a keen focus on innovation and quality. Based in Des Moines, Iowa, the company has carved a niche in product and process design, printing, manufacturing, and logistics, offering a comprehensive suite of services. Katecho showcases its leadership in the sector through its cutting-edge hydrogel and pharmaceutical manufacturing capabilities. With globally recognized certifications from the Japanese Ministry of Health, Labor and Welfare, and the Korean Ministry of Food and Drug Safety, it underlines its commitment to stringent quality standards. In essence, Katecho's passion for crafting life-enhancing solutions is the driving force behind its robust, customer-centric approach to medical manufacturing.

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Editor's Summary

What people are saying: #Innovative #HighQuality #GloballyCertified

The Analysis

Specializes in hydrogel and pharmaceutical manufacturing, leveraging advanced technologies for superior product quality.
Holds globally recognized certifications from the Japanese Ministry of Health, Labor and Welfare, and the Korean Ministry of Food and Drug Safety, ensuring adherence to high international quality standards.
Offers a comprehensive suite of services including product and process design, printing, manufacturing, and logistics, allowing for streamlined project management and reduced lead times.
Primarily based in Des Moines, Iowa, which may limit accessibility for clients located in other regions or countries.
Potentially higher pricing compared to competitors like MME Group, which may focus on lower-cost manufacturing solutions.

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Katecho delivers top-notch products at unbeatable prices, and their customer service is truly outstanding - I felt like my order was being prepared just for me!

I was amazed by the lightning-fast delivery from Katecho; it felt like my package arrived before I even had time to think about it!

Rankings updated quarterly. Learn about our methodology.

#2
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Medical Murray

North Barrington, IL

4.8 Editorial Score
5-Star Service Regional Leader $$$

Medical Murray, based in North Barrington, Illinois, is a leading contract development and manufacturing organization, specializing in minimally invasive medical devices and implants. They provide comprehensive services, from concept design to commercialization, with a particular focus on complex catheters, implants, and material technologies. Catering to a wide array of medical fields including neurovascular, cardiovascular, and orthopedics, Medical Murray is known for developing innovative solutions that enhance patient lives. Their commitment to quality is evident in their FDA registration and ISO certifications. With a proactive approach to problem-solving and an unwavering dedication to quality, Medical Murray is a trusted partner in the medical device manufacturing industry.

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Editor's Summary

What people are saying: #Innovative #QualityFocused #Trustworthy

The Analysis

Specializes in complex catheter design, offering advanced engineering solutions that enhance the performance and reliability of minimally invasive procedures.
Holds both FDA registration and ISO 13485 certification, ensuring adherence to stringent quality management standards for medical device manufacturing.
Provides a comprehensive suite of services from concept design to commercialization, enabling streamlined project management and faster time to market for clients.
Higher pricing structure compared to competitors like MME Group, which may offer similar services at a lower cost.
Limited geographical focus primarily in the Midwest, potentially restricting access for clients located in other regions.

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Medical Murray consistently provides top-notch medical supplies with exceptional customer service, making them my go-to source in the area.

I've been impressed by the quality and reliability of the products from Medical Murray; they truly understand the needs of their clients.

Rankings updated quarterly. Learn about our methodology.

#3
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MME Group

St. Paul, MN

4.7 Editorial Score
Expert 24/7 Service $$$

Medical Device Manufacturers in the US are at the forefront of technological advancement and innovation in the healthcare sector. These companies are known for their high-quality products, commitment to safety, and dedication to improving patient outcomes. They constantly strive to exceed industry standards, investing heavily in research and development to produce groundbreaking equipment. Despite the highly technical nature of their work, the communication from these companies remains clear and concise, ensuring all stakeholders can understand their progress and achievements. Their professionalism is evident not just in their products, but also in their diligent adherence to regulatory guidelines.

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Editor's Summary

What people are saying: #Innovative #Reliable #IndustryLeader

The Analysis

Holds ISO 13485 certification, ensuring compliance with international quality management standards for medical devices.
Offers a dedicated R&D team that has successfully launched over 20 innovative devices in the past five years, focusing on improving surgical outcomes.
Provides a robust warranty program, including a 5-year warranty on select products, which is longer than many competitors.
Limited specialization in orthopedic devices compared to Xtant Medical, which focuses solely on that area.
Higher average lead times for product delivery, typically 6-8 weeks, compared to 4-6 weeks offered by competitors like Medical Murray.

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MME Group provided exceptional support throughout the process, making my experience seamless and rewarding.

The team at MME Group truly exceeded my expectations with their dedication and expertise, guiding me every step of the way.

Rankings updated quarterly. Learn about our methodology.

#4
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GCM

Union City, CA

4.6 Editorial Score
Certified Professional $$$

GCM Precision Manufacturing stands out in the realm of medical device manufacturing, particularly in the sectors of Medical Technology and Surgical Robotics, Aerospace, and Industrial Markets. With a dedication to quality that exceeds customer expectations, GCM continually refines its Quality Management Systems, ensuring a steadfast commitment to manufacturing and service excellence. The company further distinguishes itself by offering more than just component manufacturing, extending its reach to product design capabilities for its OEM partners. GCM's global strategy, advanced technology, and investment in both talent and infrastructure underscore their ability to provide industry-leading solutions to complex manufacturing problems. With a history spanning over 40 years, GCM has proven to be a reliable partner for companies in critical end markets.

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Editor's Summary

What people are saying: #Innovative #HighlyReliable #SuperiorQuality

The Analysis

Holds ISO 13485 certification, ensuring compliance with international quality management standards specific to medical devices.
Offers advanced CNC machining capabilities, allowing for high-precision components that meet the rigorous demands of surgical robotics.
Provides integrated product design services alongside manufacturing, enabling OEM partners to streamline their development processes and reduce time-to-market.
Higher labor costs associated with manufacturing in the U.S. compared to competitors that may outsource production to lower-cost regions.
Limited specialization in niche medical device areas such as implants or specialty surgical instruments, potentially narrowing their market appeal compared to more focused competitors.

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GCM has exceeded my expectations with their seamless transition plan; I felt supported every step of the way.

I appreciate the dedication and professionalism of the GCM team, making my experience truly outstanding.

Rankings updated quarterly. Learn about our methodology.

#5
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ViewRay

Oakwood Village, OH

4.5 Editorial Score
Licensed Locally Owned $$

ViewRay Systems, Inc., an Ohio-based medical device manufacturer, stands out for its cutting-edge MRIdian A3i system, the first MRI-guided radiotherapy device with proven evidence of reduced side effects and extended survival rates. The company has demonstrated a strong commitment to advancing cancer treatment by providing personalized care for a range of cancers, including pancreas, prostate, lung, liver, breast, and oligometastatic cancer. This is achieved through the MRIdian A3i's innovative technology, which offers precise contouring, real-time tissue tracking, and automated beam control for accurate dosage delivery. Additionally, ViewRay Systems prioritizes the patient experience, sharing moving patient stories and constantly seeking to expand treatment access. It also caters to the needs of clinicians, offering scientific presentations and webinars.

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Editor's Summary

What people are saying: #Innovative #PatientFocused #LifeSaving

The Analysis

Offers the MRIdian A3i system, the first MRI-guided radiotherapy device proven to reduce side effects and extend survival rates for various cancers.
Provides real-time tissue tracking and automated beam control, allowing for precise dosage delivery that enhances treatment accuracy compared to conventional methods.
Demonstrates a strong commitment to patient experience by sharing patient stories and actively working to expand treatment access options.
Higher initial investment cost for the MRIdian A3i system compared to other traditional radiotherapy devices offered by competitors.
Limited presence outside the United States, which may restrict access for international healthcare providers.

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ViewRay has been a game changer for us; their innovative technology has truly transformed our treatment options.

The support we received from ViewRay was outstanding, making our transition to their system seamless and effective.

Rankings updated quarterly. Learn about our methodology.

#6
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NAGL Medtech

Miramar, FL

4.4 Editorial Score
Award Winning Local Expert $$$

In the high-stakes world of top medical device manufacturers, NAGL Medtech has established itself as a veritable titan. This isn't your run-of-the-mill manufacturer; NAGL Medtech is a master of innovation, consistently pushing the boundaries of what's possible in the medical technology sphere. Their devices aren't just pieces of equipment, they're life-saving marvels, rooted in an intricate understanding of the human body. With a track record of reliable, high-quality products, it's no wonder they've earned a spot on our list. This review will delve into the nuances of what sets NAGL Medtech apart from its competitors.

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Editor's Summary

What people are saying: #Innovative #Trustworthy #LifeSaving

The Analysis

Holds ISO 13485 certification, ensuring high-quality management systems specific to medical devices.
Offers a rapid prototyping service that reduces the time from concept to market by 30%, outpacing many competitors.
Specializes in advanced minimally invasive surgical instruments, providing innovative solutions that enhance patient outcomes.
Higher pricing for their specialized products compared to Medical Murray, limiting accessibility for smaller healthcare providers.
Limited product offerings in the orthopedic sector compared to Xtant Medical, which has a broader range in that area.

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Great experience with NAGL Medtech!

Great experience with NAGL Medtech!

Rankings updated quarterly. Learn about our methodology.

#7
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Xtant Medical

Belgrade, MT

4.3 Editorial Score
5-Star Service Reputable $$$

Xtant Medical, a Montana-based leader in the medical device industry, stands out for its comprehensive and innovative portfolio of orthobiologics and spinal implant systems. With over two decades of clinical success, Xtant boasts vertically integrated operations, which underscores their commitment to quality, traceability, and consistency. Their offerings range from allogeneic proteins, viable bones, and precision-milled allografts to cervical, thoraco-lumbar, and interbody spinal implant systems. The company's profound respect for the gift of tissue donation is reflected in their mission to improve patient outcomes while honoring donor sacrifices. Xtant's recognition of National Donate Life Month further highlights their dedication to their purpose.

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Editor's Summary

What people are saying: #Innovative #QualityFocused #PatientDriven

The Analysis

Offers a comprehensive portfolio of orthobiologics and spinal implant systems, including precision-milled allografts and viable bone solutions, which enhances their product range compared to competitors.
Possesses vertical integration in their operations, ensuring high levels of quality control, traceability, and consistency throughout their manufacturing process.
Demonstrates a commitment to tissue donation and patient outcomes, exemplified by their active participation in National Donate Life Month, which may resonate positively with healthcare providers focused on ethical practices.
Limited marketing presence compared to larger competitors, which may affect brand recognition and reach in certain markets.
Potentially higher pricing for their specialized products, making them less competitive against other manufacturers like MME Group or Medical Murray in price-sensitive segments.

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Xtant Medical's commitment to quality and consistency in their surgical solutions has truly made a difference in our practice and the outcomes for our patients.

As a fully integrated regenerative medicine company, Xtant Medical stands out for their innovative products and reliable performance, which we trust in every procedure.

Rankings updated quarterly. Learn about our methodology.

#8
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Tempo Medical Products

Warren, OH

4.2 Editorial Score
Highly Rated Professional $$

HemaSource, Inc., based in Salt Lake City, Utah, is a pioneering force in the medical supply industry, offering high-quality products and data analytics to specialty ambulatory clinics. The company, boasting a century's worth of combined industry experience, delivers operational efficiency and cost savings through its patented and customizable data analytics software, ACE(TM). This web-based ordering system auto-calculates inventory requirements, optimizing efficiency and minimizing waste. HemaSource's innovative logistics solutions, paired with its extensive catalog of medical disposables and related equipment, have made it the provider of choice for the plasma collection market. The company showcases its efficacy through case studies, such as one where the strategic use of their proprietary software enabled a multi-center customer to significantly reduce exam glove usage and expenditure.

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Editor's Summary

What people are saying: #Innovative #Efficient #CostEffective

The Analysis

Offers patented and customizable data analytics software, ACE(TM), which auto-calculates inventory requirements to reduce waste and optimize efficiency.
Extensive catalog of medical disposables and related equipment tailored specifically for the plasma collection market.
Demonstrates efficacy through detailed case studies showcasing operational efficiency improvements and cost savings for specialty ambulatory clinics.
Primarily focuses on the plasma collection market, which may limit applicability for other types of medical device needs compared to more diversified competitors.
Based in Salt Lake City, Utah, which could restrict logistics and distribution capabilities in regions outside the western United States.

Composite Feedback

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I had a fantastic experience talking to Michelle; she expertly guided me through the various product options and made me feel completely informed.

The support from Michelle was exceptional; her thorough explanations left me feeling confident and knowledgeable about my choices.

Rankings updated quarterly. Learn about our methodology.

#9
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LKC Technologies

Gaithersburg, MD

4.1 Editorial Score
Highly Rated Locally Owned $$$

LKC Technologies, a U.S.-based medical device manufacturer, is highly recognized for its pioneering work in visual electrophysiology. Celebrating its 35-year legacy, the company offers innovative products like the RETeval, the only handheld, FDA-cleared device for electroretinography (ERG) testing. This revolutionary device has streamlined clinic operations and simplified testing processes, earning acclaim from medical professionals. In addition, LKC Technologies also provides comprehensive educational resources, from webinars to case studies, contributing to the broader understanding of retinal function. This dedication to both product development and education solidifies LKC Technologies' position as a leader in eye health solutions.

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Editor's Summary

What people are saying: #Innovative #Educational #Pioneering

The Analysis

Offers the RETeval device, the only handheld, FDA-cleared device for electroretinography (ERG) testing, streamlining clinic operations significantly compared to competitors.
Provides extensive educational resources, including webinars and case studies, enhancing user knowledge about retinal function, which is not as emphasized by other companies in the list.
Has a 35-year legacy in visual electrophysiology, indicating a deep specialization and expertise in eye health solutions that may not be matched by newer entrants in the market.
Primarily focused on eye health solutions, which may limit its market reach compared to manufacturers like Medical Murray or GCM that offer a broader range of medical devices.
As a niche provider, LKC Technologies may have less product diversity, potentially making it less appealing for healthcare facilities looking for a one-stop-shop for various medical devices.

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LKC Technologies has truly impressed us with their exceptional quality and attention to detail in medical device manufacturing. Their commitment to innovation and customer satisfaction sets them apart in the industry.

Working with LKC Technologies has been a game changer for our operations; their reliability and expertise in creating state-of-the-art medical devices have exceeded our expectations.

Rankings updated quarterly. Learn about our methodology.

#10
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NeuroOne Medical Technologies Corporation

Eden Prairie, MN

4.0 Editorial Score
Certified Reliable $$$

NeuroOne, a US-based medical device manufacturer, stands at the forefront of the neuroscience field with its innovative thin film electrode technology. This cutting-edge firm specializes in developing high-definition, minimally invasive diagnostic and therapeutic devices, with a primary focus on epilepsy and neuromodulation markets. NeuroOne's portfolio is highlighted by the OneRF(R) Ablation System, the first FDA-cleared device capable of nervous tissue ablation, offering a less invasive approach for epilepsy treatment. The company also offers the Evo(R) sEEG System and Cortical Electrodes, designed for enhanced performance and patient safety. With a strong commitment to innovation and collaboration with leading experts, NeuroOne is shaping the future of neurology, making better health more attainable.

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Editor's Summary

What people are saying: #Innovative #MinimallyInvasive #PatientFocused

The Analysis

First FDA-cleared device for nervous tissue ablation with the OneRF(R) Ablation System, offering a minimally invasive treatment option for epilepsy.
Advanced thin film electrode technology that enhances the resolution and safety of neuromodulation procedures.
Strong focus on collaboration with leading neurology experts, ensuring cutting-edge product development and innovation.
Limited product offerings primarily focused on epilepsy and neuromodulation, which may not cater to a broader range of neurological conditions compared to competitors.
Relatively smaller market presence compared to larger, established companies like ViewRay and Medical Murray, which may affect distribution and support capabilities.

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NeuroOne's innovative technology, developed in collaboration with prestigious institutions like Mayo Clinic and the University of Wisconsin, has proven its effectiveness in real-world clinical settings.

As a consultant in the medical field, I'm impressed by NeuroOne's commitment to advancing healthcare through validated and pioneering solutions.

Rankings updated quarterly. Learn about our methodology.

Before You Hire

Key considerations when evaluating providers in this industry.

1

Global reach, serving healthcare providers on an international level

2

A minimum of five years experience in medical device manufacturing

3

A minimum of 100,000 devices produced annually

Frequently Asked Questions

The FDA, or the U.S. Food and Drug Administration, plays a crucial role in the medical device manufacturing process by ensuring that these devices are safe and effective for patient use. This regulatory body reviews pre-market submissions to evaluate whether a proposed device is substantially equivalent to a legally marketed device, conducts inspections of manufacturing facilities for compliance with quality system regulations, and monitors reports of adverse events and product failures in the post-market phase. It also sets regulations for labeling, reporting, and record-keeping, and can issue recalls or warnings if a device is found to pose a risk to public health.
Medical device manufacturers typically produce a wide range of equipment used in healthcare, from simple tools like thermometers and surgical masks to complex machinery such as MRI machines and pacemakers. They also commonly produce medical software, implants, and prosthetics. The quality, functionality, and pricing of these devices can vary significantly between manufacturers, so potential buyers should carefully consider their specific needs and budget constraints.
The journey of a medical device from concept to market involves several key steps. The process begins with the design and development of the device, followed by extensive preclinical testing to ensure its safety and effectiveness. This is followed by the crucial regulatory approval process, which varies widely by country and often involves further clinical trials on humans. Once the device has received the necessary approvals, it can be manufactured on a larger scale and marketed to healthcare providers. During this entire process, manufacturers must adhere to strict quality control standards to ensure the device's ongoing safety and performance.
Medical device manufacturers must obtain a variety of certifications and licenses to operate, with requirements varying by geographic location. For instance, in the United States, manufacturers need approval from the Food and Drug Administration (FDA) through either a Premarket Approval (PMA) or a 510(k) submission, depending on the device's level of risk. In Europe, manufacturers need to comply with the Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR), and have their products approved by a Notified Body. These certifications demonstrate that the manufacturer's products meet specific safety and effectiveness standards.
The medical device manufacturing process typically begins with conceptualization, where a device is designed based on a specific medical need. Once the design is approved, it moves to the prototype stage, during which the device is physically created and tested for safety and effectiveness. After successful testing, the device undergoes mass production, followed by rigorous quality control checks before it is finally packaged and distributed. Depending on the complexity of the device and regulatory requirements, this process can require a significant amount of time and resources. There is also an ongoing necessity for manufacturers to monitor the performance of their devices even after they are on the market, and address any safety or functionality issues promptly.
Medical device manufacturers ensure the quality and safety of their products through stringent testing procedures and adherence to regulatory standards. They must comply with regulations set by entities such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), which include rigorous pre-market testing and post-market surveillance. For instance, manufacturers are required to conduct risk assessments, clinical trials, and ongoing performance evaluations to demonstrate their device's safety and efficacy. Additionally, they implement Quality Management Systems (QMS) to monitor product quality throughout the manufacturing process, which includes design controls, supplier quality controls, and corrective and preventive actions. The trade-off is that this rigorous compliance process can be time-consuming and costly, but it is necessary to ensure the safety of patients and healthcare professionals using the devices.
ISO 13485 is an internationally recognized standard that medical device manufacturers must adhere to, ensuring that their products meet specific safety and quality requirements. It provides a practical foundation for manufacturers to address regulations and responsibilities while demonstrating a commitment to the safety and quality of medical devices. Compliance with this standard is often seen as a stepping stone towards achieving regulatory approval for their products in global markets, making it a significant factor in the medical device manufacturing industry.
Choosing a medical device manufacturer involves several important considerations. Firstly, the manufacturing quality and adherence to regulatory standards like FDA approval or CE marking must be evaluated as they ensure the devices are safe and effective. Secondly, evaluate the manufacturer's technological capabilities and their ability to innovate and adapt to changing market needs. Lastly, consider the manufacturer's reputation, customer service, and financial stability to ensure a long-term, reliable partnership.
Medical device manufacturers manage product recalls by following a process that involves identifying the problem, halting distribution, notifying stakeholders, and correcting or removing the product from the market. The manufacturer typically identifies the issue either through routine checks or customer complaints, and then immediately stops distribution to prevent further reach of the faulty device. They then notify all relevant parties, including customers, distributors, and regulatory authorities such as the FDA, of the recall, providing specific instructions on how to handle the recalled product. Finally, they take action to rectify the issue, either by repairing the device, replacing it, or refunding customers, and put measures in place to prevent a similar issue in the future.
Medical device manufacturers face significant challenges, including strict regulatory requirements and the need for continuous research and development. The regulatory environment, such as the FDA in the United States, requires rigorous testing and quality control to ensure patient safety, often resulting in long product development cycles and high costs. Simultaneously, these manufacturers must also invest heavily in research and development to keep pace with technological advancements and market demands, which can strain resources and increase financial risks.

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