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DEVICE TECHNOLOGIES NEW ZEALAND LIMITED
Auckland, New Zealand
A
51-100 Employees
2000
Key takeaway
Device Technologies is committed to enhancing patient care through innovative medical devices and solutions, ensuring compliance with quality regulatory standards. Their extensive portfolio and partnership with healthcare professionals highlight their role as a key supplier in the medical technology field.
Reference
Core business
Device Technologies NZ | Medical Devices & Supplies
Medical Device Pros LLC
Satellite Beach, United States
B
1-10 Employees
2010
Key takeaway
Medical Device Pros, LLC highlights its expertise in developing and engineering medical devices, including a revolutionary breast implant with FDA approval and advancements in cardiology products. Their services encompass patent development, prototype creation, and crisis mitigation, specifically addressing data analysis needs for successful FDA submissions.
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
DigiLife
Frisco, United States
B
1-10 Employees
2014
Key takeaway
The company is a healthcare technology firm that develops interoperable electronic health records (EHR) and telemedicine products, emphasizing connected care and telehealth solutions. Their focus on innovative healthcare delivery aims to enhance patient engagement and improve outcomes.
Reference
Product
A Healthcare Technology Company
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Mediantis Consult GmbH
Ermatingen, Switzerland
A
1-10 Employees
2012
Key takeaway
The company offers specialized consulting services tailored for the Medical Device industry, emphasizing their commitment to understanding and addressing client needs.
Reference
Service
MEDICAL DEVICE
Medical Device Partners
Regensburg, Germany
A
1-10 Employees
2001
Key takeaway
Medical Device Partners is dedicated to fostering long-term relationships in the medical devices industry, advising suppliers and manufacturers on market entry and business expansion. With a strong presence in Europe, particularly Germany, they represent a diverse range of medical products and services.
Reference
Core business
Contact Details Medical Device Partners | Home
Medical Device Management Ltd
United Kingdom
A
1-10 Employees
2000
Key takeaway
Medical Device Management specializes in assisting medical device companies in navigating regulatory requirements, such as the Medical Device Directive and Medical Device Regulations. Their ISO 13485:2016 certified quality management system ensures they provide tailored support to help clients successfully bring their products to market.
Reference
Service
Services | Medical Device Management Ltd
Device Technologies Australia
Sydney, Australia
A
501-1000 Employees
1992
Key takeaway
Device Technologies has been committed to enhancing patient care through innovative medical technologies and services since 1992. With a comprehensive portfolio that serves various healthcare sectors, the company ensures that all its products meet quality regulatory standards, providing ongoing support to healthcare professionals.
Reference
Core business
Device Technologies AU | Medical Devices & Supplies
eDevice
Mérignac, France
A
11-50 Employees
1999
Key takeaway
eDevice specializes in connected health solutions, offering the HealthGO platform, which facilitates the acquisition, monitoring, and transmission of medical data for Remote Patient Monitoring (RPM). Their commitment to quality is underscored by ISO certifications and the inclusion of FDA-listed devices, making them a trusted provider in the healthcare sector.
Reference
Core business
Remote Patient Monitoring – eDevice – Mérignac, France
The leading provider of global IoT connectivity solutions.The leading provider of global IoT connectivity solutions.HealthGO, an award-winning medical hub, is a simple way to acquire, monitor and transmit medical data to the cloud for Remote Patient Monitoring applications.
Medical Device Alliance
Frisco, United States
B
1-10 Employees
2009
Key takeaway
Medical Device Alliance is a leading provider of aesthetic medical devices, offering a range of services including the sale of inspected pre-owned and new equipment, training, and laser rental services. Their focus on delivering value and long-term success for clients makes them a key player in the medical device market.
Reference
Core business
Medical Device Alliance | Buy and Sell Lasers | United States
Medical Device Alliance is the market leader in aesthetic solutions. We help our clients find the best value for their long term success by offering inspected pre-owned equipment, new equipment, training, laser rental services, financing, and business consulting.
ION Design
Edgewater, United States
B
1-10 Employees
1994
Key takeaway
Sterling Medical Devices is a dedicated medical device engineering firm that assists clients throughout the entire design and development process, ensuring compliance with FDA guidelines. Their expertise covers all aspects of medical device development, helping to optimize budgets and shorten timelines for various classes of devices.
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 […]
Technologies which have been searched by others and may be interesting for you:
A medical device is any instrument, apparatus, implement, machine, or related article that is intended for use in the diagnosis, prevention, monitoring, treatment, or alleviation of disease. These devices can range from simple tools, such as bandages or thermometers, to complex machinery like MRI machines and surgical robots. In addition to their primary functions, medical devices often play a crucial role in enhancing patient care and improving health outcomes. They must comply with strict regulatory standards to ensure safety and effectiveness, making them essential components of modern healthcare.
Medical devices serve various functions based on their design and intended use. Generally, they operate by measuring, monitoring, or aiding in the treatment of medical conditions. For instance, diagnostic devices like ultrasound machines utilize sound waves to create images of the inside of the body, allowing healthcare professionals to assess a patient's condition. Therapeutic devices, such as pacemakers, actively regulate bodily functions. They deliver electrical impulses to the heart to maintain proper rhythm. Additionally, surgical instruments facilitate procedures by offering precision and control during operations. Each device's function is crucial for enhancing patient care and improving health outcomes in clinical settings.
Regulatory requirements for medical devices vary by country but generally include rigorous processes to ensure safety and efficacy. In the United States, for example, the Food and Drug Administration (FDA) oversees the approval of medical devices through classifications based on risk levels, which dictate the necessary premarket submissions. Devices categorized as Class I typically require less regulatory control, whereas Class II and Class III devices may need more extensive evidence, including clinical trials and a premarket approval (PMA) process. In the European Union, the Medical Device Regulation (MDR) outlines comprehensive requirements for manufacturers, including technical documentation, conformity assessment, and post-market surveillance. Compliance with ISO standards, such as ISO 13485 for quality management systems, is also essential. Meeting these regulatory requirements is crucial for medical device providers to ensure their products are safe, effective, and market-ready.
Medical devices are classified based on their intended use and the level of risk associated with them. The classification system typically divides medical devices into three categories:
1. Class I
These devices present minimal risk to patients and are subject to the least regulatory control. Examples include bandages and handheld surgical instruments.
2. Class II
Devices in this category are considered to have moderate risk. They usually require more regulatory controls to ensure safety and effectiveness, such as performance standards or post-market surveillance. Examples include infusion pumps and X-ray machines.
3. Class III
These devices pose the highest risk and are critical for sustaining life or preventing impairment. They require the most stringent regulatory controls, including premarket approval. Examples include pacemakers and implantable defibrillators.
This classification helps ensure that medical devices are safe and effective for their intended use.
Safety standards for medical devices are critical to ensure the health and well-being of patients. These standards are established by regulatory bodies such as the FDA in the United States and the European Medicines Agency (EMA) in Europe. Manufacturers must adhere to rigorous testing and quality control measures, demonstrating that their devices are safe and effective for intended uses. The International Organization for Standardization (ISO) also plays a significant role by providing guidelines, such as ISO 13485, which focuses on quality management systems for medical devices. Compliance with these standards involves extensive documentation, risk management processes, and post-market surveillance to monitor the device's performance after it has been approved for use. Regular audits and assessments ensure ongoing compliance, ultimately protecting patient safety.
Some interesting numbers and facts about your company results for Medical Device
| Country with most fitting companies | United States |
| Amount of fitting manufacturers | 7962 |
| Amount of suitable service providers | 6759 |
| Average amount of employees | 1-10 |
| Oldest suiting company | 1992 |
| Youngest suiting company | 2014 |
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Some interesting questions that has been asked about the results you have just received for Medical Device
What are related technologies to Medical Device?
Based on our calculations related technologies to Medical Device are Big Data, E-Health, Retail Tech, Artificial Intelligence & Machine Learning, E-Commerce
Which industries are mostly working on Medical Device?
The most represented industries which are working in Medical Device are Medical, Healthcare, Other, IT, Software and Services, Electronics and Electrical engineering
How does ensun find these Medical Device Companies?
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.
