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Zhuhai Specialife Co., Ltd.
Zhuhai, China
D
1001-5000 Employees
2006
Key takeaway
The company specializes in providing innovative and high-quality components for medical devices, offering complete turn-key solutions from design to manufacturing. With over 30 years of experience, they ensure superior performance in medical applications through customized molding services and a comprehensive quality management system.
Reference
Service
MEDICAL DEVICE COMPONENTS – Specialife Industries Ltd
We provide innovative, high quality and advanced products and solutions for superior performance in medical applications.
Medical Device Pros LLC
Satellite Beach, United States
B
1-10 Employees
2010
Key takeaway
Medical Device Pros, LLC specializes in engineering consulting for the medical device industry, highlighting their recent work in cardiology product development and their expertise in data analysis, which was critical for a successful FDA submission. They also emphasize their innovative approaches, such as combining silicone with functional ingredients to enhance the properties of medical devices.
Reference
Core business
Medical Device Pros, LLC - Engineering Consultant, Medical Device
Engineering consultants for manufacturers, consultants, physicians, inventors. Patent, Development, Prototype, Crisis Mitigation, Troubleshooting, Data Analysis
Paragon Medical
Pierceton, United States
B
501-1000 Employees
1991
Key takeaway
Paragon Medical specializes in providing a wide range of specialist components for various healthcare applications, including medical devices. They offer expertise in the manufacturing of precision components for diagnostic equipment and testing devices, supporting healthcare manufacturers in bringing innovative products to market.
Reference
Service
Diagnostic Device & Testing Components | Paragon Medical
Complex metal & plastic parts for diagnostic testing equipment. Paragon manufactures diagnostic device components for medical applications.
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Cirtec Medical
Enfield, United States
B
101-250 Employees
2009
Key takeaway
Cirtec Medical specializes in the design, development, and manufacturing of complex medical devices and components, offering over three decades of expertise. Their recent acquisition of QMD’s Precision Components enhances their capabilities in producing custom elastomeric components, positioning Cirtec as a full-service outsource partner for bringing innovative medical devices to market efficiently and cost-effectively.
Reference
Service
Medical Device & Component Manufacturing | Vertically Integrated Manufacturing Capabilities
Cirtec is a leader in medical device & component manufacturing & development, delivering the highest quality components quickly, with unrivalled precision
Degania Medical
Pepper Pike, United States
B
1001-5000 Employees
-
Key takeaway
The company, QMD, specializes in manufacturing silicone-based components and devices for OEMs, offering a comprehensive range of products and services to support the development and market entry of medical devices. Their commitment to patient safety and improved outcomes is reflected in their tailored solutions, clean room packaging, and various sterilization methods.
Reference
Service
Capabilities | QMD™
End-to-end medical device products & services QMD specializes in manufacturing silicone-based components and devices for OEMs.
DG Medical
Centerville, United States
B
51-100 Employees
2009
Key takeaway
DG Medical is a trusted supplier of high-quality plastic molded components for leading medical device OEMs, highlighting their expertise in engineering and manufacturing. With ISO13485 certification, they offer molding solutions and assembly services, ensuring the highest quality standards for medical device components.
Reference
Core business
DG Medical - Contract Manufacturer for Medical Devices
Contract Manufacturer for Medical Devices
Orchid Orthopedic Solutions
Delhi Charter Township, United States
B
- Employees
1990
Key takeaway
Orchid Orthopedic Solutions specializes in assisting the development of medical devices, offering a comprehensive range of services from manufacturing to packaging, with a focus on efficient design and supply chain optimization for products like orthopedic implants.
Reference
Service
Medical Devices & Services | Orchid Orthopedic Solutions
Advant Medical
Galway, Ireland
A
101-250 Employees
1993
Key takeaway
Advant Medical specializes in the development and manufacturing of Class I, II, and III medical device components, offering custom solutions and expertise to ensure safety and effectiveness. With certifications and a global presence, they are a key partner for medical device companies.
Reference
Core business
Innovative Medical Device Solutions | A Global Partner | Advant Medical
We are the leading partner of choice to international medical device companies for the design & manufacture of Class I, II, III Medical devices. Talk to us today.
ION Design
Edgewater, United States
B
1-10 Employees
1994
Key takeaway
Sterling Medical Devices is a dedicated medical device engineering firm that supports clients throughout the design and development process, ensuring compliance with FDA guidelines. Their expertise covers all aspects of development, making them well-equipped to address challenges related to medical device components.
Reference
Service
Medical Device Regulatory Compliance Consultants
The FDA is responsible for regulating the production and monitoring the safety of high-quality medical devices. Before the device can be sold in the U.S., the manufacturer must obtain FDA […]
CEDIC SRL DIVISIONE STAMPAGGIO
Novi di Modena, Italy
B
11-50 Employees
1988
Key takeaway
The company specializes in producing medical devices and components that enhance patient quality of life, with a focus on fluid delivery systems. They have over 50 years of experience in the medical devices industry, ensuring quality through controlled sourcing and collaboration with standards organizations.
Reference
Core business
About Us | Cedic
Technologies which have been searched by others and may be interesting for you:
A medical device component refers to any part or element that contributes to the functionality of a medical device. These components can include mechanical parts, electronic circuits, sensors, and software that work together to ensure the device operates effectively and safely. The quality and reliability of these components are crucial, as they directly impact the performance and compliance of the medical device with regulatory standards. Manufacturers often source these components from specialized suppliers to meet specific requirements in terms of safety, effectiveness, and technological advancement.
Medical device components play a crucial role in determining the overall functionality and performance of medical devices. Each component, whether it is a sensor, actuator, or microcontroller, contributes to the device's ability to perform specific tasks accurately. For example, high-quality sensors ensure precise data collection, which is vital for devices like blood glucose monitors. Furthermore, the integration of advanced materials and innovative designs in components enhances durability and user experience. This results in improved patient outcomes, as reliable components minimize the risk of failure and ensure consistent operation. Overall, the effectiveness of a medical device is heavily reliant on the quality and compatibility of its components.
Various materials are utilized in medical device components to ensure safety, functionality, and biocompatibility. Stainless steel is widely favored for its strength and corrosion resistance, making it ideal for surgical instruments and implants. Another commonly used material is plastics , particularly polycarbonate and polyethylene, which are lightweight and can be easily molded into intricate shapes. These materials are often used in devices like syringes and catheters. Additionally, ceramics are employed for their durability and biocompatibility, often found in dental implants and prosthetics.
Quality control in medical device component manufacturing is critical to ensuring the safety and efficacy of the final products. Manufacturers implement a robust quality management system (QMS) that adheres to regulatory standards such as ISO 13485. This involves rigorous testing and inspection processes at various stages of production. In-process inspections are conducted to monitor production consistency, while final product evaluations ensure that components meet predefined specifications. Additionally, manufacturers often utilize statistical process control (SPC) techniques to analyze manufacturing data, helping to identify trends and potential issues before they impact quality. Continuous training for personnel and regular audits further enhance the quality assurance framework, fostering an environment that prioritizes precision and compliance.
Regulatory requirements for medical device components vary by region and are crucial for ensuring safety and efficacy. In the United States, the Food and Drug Administration (FDA) oversees the classification and regulation of medical devices. Components may be classified into Class I, II, or III, with corresponding levels of regulatory scrutiny. Class I components typically require general controls, while Class II may necessitate premarket notification (510(k)), and Class III components usually require premarket approval (PMA). In Europe, the Medical Device Regulation (MDR) mandates that components comply with essential safety and performance requirements. This includes thorough documentation, risk management, and post-market surveillance. Manufacturers must also ensure their components carry the CE mark, indicating conformity with European standards. Adhering to these regulations not only facilitates market access but also enhances product reliability and patient safety.
Some interesting numbers and facts about your company results for Medical Device Component
| Country with most fitting companies | United States |
| Amount of fitting manufacturers | 8580 |
| Amount of suitable service providers | 7481 |
| Average amount of employees | 101-250 |
| Oldest suiting company | 1988 |
| Youngest suiting company | 2010 |
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Some interesting questions that has been asked about the results you have just received for Medical Device Component
What are related technologies to Medical Device Component?
Based on our calculations related technologies to Medical Device Component are Biomedical (Red), Bioinformatics (Gold), Environmental Biotechnology (Grey), Agricultural Biotechnology (Green), Food Related Biotechnology (Yellow)
Which industries are mostly working on Medical Device Component?
The most represented industries which are working in Medical Device Component are Medical, Other, Electronics and Electrical engineering, Healthcare, Manufacturing
How does ensun find these Medical Device Component 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.
