What we can help you with

There are many different types of data systems that the FDA requires for medical devices. The Wi4 Corporation’s products and services can help you meet these requirements. Our company specializes in full-service life cycle management for medical device data systems, from development and installation to support and maintenance. We understand the regulations and guidelines that the FDA has put in place, and our team is experienced in working with all kinds of data systems. With our help, you can be sure that your medical device data system will be compliant with all FDA requirements. Contact us today to learn more about how we can help you!

Embedded Software Development

What Sets Us Apart

20 years + experience of delivering healthcare apps​

Digital Health software developed by us has been used by 2 million-plus users​

Federal Government, State Governments, Large Corporations and Startups have trusted us for their digital health product requirements

Our founders have published more than 200 research papers in health informatics. Ongoing research keeps us always updated.​

Expertise in various healthcare standards like Hl7 & FHIR, IEC 60234, HIPAA, HITECH, ICD-10, CPT, DICOM​

Member of HL7 Development Body​

Frequently Asked Questions

MDDS FDA

Yes, MDDS is classified as a Class 1 medical device. This classification is given to devices that pose little or no threat to the user’s health or well-being. As such, MDDS systems are subject to less stringent regulations than other types of medical devices.

MDDS systems are designed to provide accurate and reliable data storage, management, and retrieval for medical records. These systems can be used by hospitals, clinics, and other healthcare facilities to improve the efficiency of their operations.

Wi4 Corporation is a leading provider of MDDS solutions. Our product offerings include enterprise-grade software and hardware components that are fully compliant with industry standards. We have a team of experienced professionals who can help you select

A medical device data system is a comprehensive solution that enables secure and efficient exchange of clinical and administrative data between medical devices, hospital information systems (HIS), and other healthcare IT systems. It can provide access to patient data across the care continuum, from pre-hospital through post-acute care settings.

A typical medical device data system integrates with a variety of different types of medical devices, such as bedside monitors, infusion pumps, ventilators, and X-ray machines. The system also interfaces with hospital information systems to collect patient demographic information, clinical diagnoses and procedures, medication orders, and other vital statistics. This information is then used to generate reports that can help improve the quality and safety of patient care.

The Medical Device Data System (MDDS) is a system that allows for the secure, interoperable exchange of medical device data. The system was developed by Wi4 Corporation and is compliant with the standards set by the International Organization for Standardization (ISO) and the Health Information Technology Standards Panel (HITSP). MDDS provides a secure platform for clinical decision support, quality assurance, and risk management.

MDDS stands for the medical device data system. It is a term used to describe a system that captures, archives, and retrieves data from medical devices.

MDDS systems are often used in hospitals to collect data from various medical devices such as patient monitors, ventilators, and infusion pumps. This data can then be used to help physicians make more informed decisions about patient care.

MDDS systems are also known as clinical information systems or healthcare information systems.

Compliances

Our Impact

We have partnered with Federal and State agencies, academia, tech startups, and well-known organizations – positively impacting over a billion lives

Reduced time to serve persons with disabilities​

Reduced time to serve persons with disabilities​

Software used by 18 states to enhance revenues and reduced time to pay to members of Ticket to Work program.

CRT Medical System: Automation of Data Exchange Process Using HL7 and Mirth Connect

CRT Medical System: Automation of Data Exchange Process…

With the implementation of Mirth Connect based customized HL7 interfaces, the tedious manual works of message submission

Improved provider productivity

Improved provider productivity

Mobile device infrastructure rolled out across large outpatient healthcare system to improve provider productivity

Members/ Contributors

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MDDS FDA

The term "MDDS" stands for Medical Device Data Systems. The MDDS regulation is found in Title 21 of the Code of Federal Regulations, Part 803. This regulation covers the recording, storage, and retrieval of medical device data by manufacturers. A manufacturer must comply with this regulation if they create, alter, retrieve, or transmit any medical device data using an electronic media (including but not limited to, an automated system). The FDA's role in regulating MDDS is to ensure that manufacturers are storing and transmitting data safely and effectively. In order to do this, the FDA has put forth a number of requirements for medical device data systems.

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Medical Device Data System

Wi4 is a leading Medical Device Data System company in Atlanta having experienced MDDS FDA Solution developers. We provide dedicated Medical Device Data System services to our customers which leads to great experience.

We have worked on Android, iOS and Windows platform and have delivered dozens of applications on various platforms to our customers. We are one of the top Medical Device Data System Solution development agencies in the United States.