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DG Medical
Centerville, United States
B
51-100 Employees
2009
Key takeaway
DG Medical is a full-service contract manufacturer for medical devices, known for its seasoned engineering and manufacturing expertise. With a focus on quality and ISO13485 certification, they provide high-quality molding solutions and assembly services to leading medical device OEMs.
Reference
Core business
DG Medical - Contract Manufacturer for Medical Devices
Contract Manufacturer for Medical Devices
Sky Medical a.s.
Šamorín, Slovakia
A
11-50 Employees
2017
Key takeaway
Sky Medical is a dedicated contract manufacturer of medical devices, offering comprehensive services that range from prototype development to large-volume production. With over 20 years of experience, they emphasize robust quality systems and a commitment to meeting the needs of their OEM partners, ensuring that the components and devices produced meet the highest standards essential for enhancing patient care.
Reference
Core business
Contract Manufacturing | Sky Medical
The company Sky Medical offers full-scale contract and legal manufacturing of medical devices and equipment: initial runs of prototypes, and large-volume production, including product assembly, packaging, sterilization, storage, and logistics.
Advant Medical
Galway, Ireland
A
101-250 Employees
1993
Key takeaway
Advant Medical is a strategic global partner specializing in contract manufacturing for Class I, II, and III medical devices, offering custom services and expertise to meet diverse client needs. With ISO 13485:2016 certification and locations in Ireland, Mexico, and Costa Rica, they ensure safe and effective product development, supporting both low and high volume requirements.
Reference
Service
Contract Manufacturing Experts | Medical Devices | Advant Medical
Our flexible & structured approach to global contract manufacturing is designed to support our customers’ low & high volume requirements.
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Leader Biomedical USA LLC
Centerville, United States
B
- Employees
2016
Key takeaway
EMCM specializes in developing and manufacturing solutions for medical devices and pharmaceuticals, highlighting its expertise in contract manufacturing. Additionally, Leader Biomedical offers comprehensive contract manufacturing services, including the production of innovative biomaterials for various medical applications, supported by ISO certifications.
Reference
Core business
Contract Manufacturing | Leader Biomedical
Leader Biomedical’s contract manufacturing operations (CMO and OEM) is an ISO 9001:2015 and ISO 13485:2016 certified company
ERI Group (Formerly Evergreen Research)
Golden, United States
B
51-100 Employees
-
Key takeaway
ERI Group specializes in medical device contract manufacturing, offering a comprehensive range of services from product design to regulatory compliance. With 35 years of experience and a focus on quality and problem-solving, they are well-equipped to support clients throughout the entire process of bringing medical innovations to market.
Reference
Service
FDA medical device contract manufacturer • ERI Group
ERI Group has 35 years experience assisting our partners as a FDA medical device contract manufacturer. Contact us for expert assistance.
Sanbor Medical
Allentown, United States
B
101-250 Employees
1987
Key takeaway
Sanbor Medical specializes in medical device contract manufacturing, leveraging over 30 years of experience and a strong commitment to documentation, compliance, and risk management. With a global manufacturing footprint and the ability to customize solutions, Sanbor Medical is well-equipped to meet diverse client needs in the medical device sector.
Reference
Core business
Medical Device Contract Manufacturing | Sanbor Medical
Quality. Savings. Compliance. Sanbor medical device contract manufacturing is there to make a difference. Learn more and contact us today!
ITL
Ashford, United Kingdom
A
51-100 Employees
1977
Key takeaway
The company offers comprehensive end-to-end design and manufacturing solutions specifically for medical devices, including support throughout development, validation, certification, and production. With a strong background in the medical and scientific industries, they position themselves as a leading contract manufacturer for life-saving technologies and diagnostic devices.
Reference
Service
Medical Device Contract Manufacturing | ITL
Domico Med-Device LLC
Fenton, United States
B
51-100 Employees
2018
Key takeaway
Domico Med-Device specializes in medical product contract manufacturing, offering a range of capabilities to design and produce high-quality, American-made medical devices. With a focus on enhancing patient and caregiver experiences, they collaborate with leading manufacturers and clinical experts to bring innovative products to market.
Reference
Service
Domico Med-Device | Medical Product Contract Manufacturing
If you're looking for a medical product contract manufacturing partner, Domico Med-Device has a history of success. Learn about our expertise here.
Contract Medical Manufacturing, Limited Liability Company
Oxford, United States
B
51-100 Employees
2006
Key takeaway
CMM is a premier full-service contract manufacturer specializing in the mechanical and electrical assembly of class 1 and class 2 medical devices. They offer a comprehensive range of services, including custom part production, device testing, packaging, and sterilization management, all in compliance with FDA and ISO standards, ensuring high-quality manufacturing tailored to customer specifications.
Reference
Service
Capabilities | Contract Medical Manufacturing
Globalink Manufacturing Solutions Inc.
Naples, United States
B
11-50 Employees
2003
Key takeaway
Globalink Manufacturing Solutions offers extensive medical device manufacturing services, utilizing both onshore and offshore facilities in the United States, China, and Taiwan. Their expertise in product development across various sectors positions them well to meet the needs of clients in the medical device industry.
Reference
Core business
medical device manufacturing services - US Offshore Manufacturer: Globalink Manufacturing Solutions
Technologies which have been searched by others and may be interesting for you:
Medical Device Contract Manufacturing refers to the process where companies outsource the production of their medical devices to specialized manufacturers. These providers offer a range of services, including design, prototyping, production, and quality assurance, ensuring compliance with regulatory standards such as ISO and FDA requirements. By partnering with contract manufacturers, medical device companies can leverage advanced technologies and expertise in manufacturing processes, ultimately enhancing efficiency and reducing costs. This collaboration allows companies to focus on their core competencies, such as research and development, while relying on the contract manufacturer’s capabilities for high-quality production.
Medical device contract manufacturing offers several advantages to companies in the healthcare sector. It allows businesses to focus on their core competencies while outsourcing the complexities of production to experts. This approach often leads to cost savings, as firms can minimize expenses related to labor, equipment, and facility maintenance. Furthermore, partnering with specialized manufacturers enhances product quality and compliance with regulatory standards. These providers bring extensive experience and technological expertise, ensuring that devices meet stringent safety and performance criteria. This collaboration can accelerate time-to-market, giving companies a competitive edge in the rapidly evolving medical landscape.
When selecting a Medical Device Contract Manufacturer, several key considerations must be taken into account.
1. Regulatory Compliance
It is crucial to ensure that the manufacturer complies with necessary regulatory standards such as ISO 13485 and FDA regulations. This compliance guarantees that the manufacturer adheres to quality management systems specifically designed for medical devices.
2. Experience and Expertise
Evaluating the manufacturer's experience in the medical device industry can provide insight into their capabilities. A provider with a strong track record in developing similar products demonstrates reliability and expertise in handling complex manufacturing processes.
3. Quality Assurance Processes
Understanding the quality assurance measures implemented by the manufacturer is vital. Robust quality control practices help to minimize defects, ensuring that the final product meets all safety and efficacy requirements.
4. Scalability and Flexibility
Consideration of the manufacturer's ability to scale production in response to demand fluctuations is important. A flexible manufacturer can adapt to changing requirements without compromising quality or timelines.
5. Communication and Collaboration
Effective communication is essential for successful partnerships. A manufacturer who fosters open dialogue and collaboration can better align with your project goals and timelines, leading to smoother development and production processes.
Various types of medical devices can be produced through contract manufacturing. These include diagnostic devices such as imaging equipment and blood testing kits, which play a crucial role in patient diagnosis. Additionally, therapeutic devices like infusion pumps and surgical instruments are also commonly manufactured. Other categories include implantable devices, such as pacemakers and orthopedic implants, as well as wearable devices that monitor health metrics. Contract manufacturing allows for the production of a wide array of devices tailored to meet specific regulatory standards and client needs.
Medical device contract manufacturing is subject to stringent regulatory requirements to ensure safety and efficacy. Manufacturers must comply with the regulations set forth by the FDA in the United States, which include adhering to the Quality System Regulation (QSR) outlined in 21 CFR Part 820. This involves establishing a quality management system that encompasses design controls, production and process controls, and proper documentation practices. Additionally, it is crucial for manufacturers to obtain the necessary certifications, such as ISO 13485, which demonstrates their commitment to quality management specific to medical devices. Compliance with International Organization for Standardization (ISO) guidelines helps facilitate market access in various countries. Regular audits and inspections by regulatory bodies are also vital to maintain compliance and demonstrate adherence to these stringent standards.
Some interesting numbers and facts about your company results for Medical Device Contract Manufacturing
| Country with most fitting companies | United States |
| Amount of fitting manufacturers | 7996 |
| Amount of suitable service providers | 8347 |
| Average amount of employees | 51-100 |
| Oldest suiting company | 1977 |
| Youngest suiting company | 2018 |
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Some interesting questions that has been asked about the results you have just received for Medical Device Contract Manufacturing
What are related technologies to Medical Device Contract Manufacturing?
Based on our calculations related technologies to Medical Device Contract Manufacturing are Biomedical (Red), Bioinformatics (Gold), Environmental Biotechnology (Grey), Agricultural Biotechnology (Green), Food Related Biotechnology (Yellow)
Which industries are mostly working on Medical Device Contract Manufacturing?
The most represented industries which are working in Medical Device Contract Manufacturing are Medical, Other, Electronics and Electrical engineering, Manufacturing, Healthcare
How does ensun find these Medical Device Contract Manufacturing Manufacturers?
ensun uses an advanced search and ranking system capable of sifting through millions of companies and hundreds of millions of products and services to identify suitable matches. This is achieved by leveraging cutting-edge technologies, including Artificial Intelligence.
