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What we can help you with

At Wi4 Corporation, we are experts in medical device software validation and compliance. Our team has many years of experience in the industry, and we are dedicated to helping our clients meet all regulatory requirements. We offer a variety of services, including software development, quality assurance, and compliance consulting. We also offer a variety of tools and resources to help our clients stay up-to-date on regulatory changes. 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

Medical Device Software Validation

The ISO 9001 standard does not specifically require software validation, but it is a requirement of the ISO 9001 standard that organizations demonstrate they have a process in place to ensure that their software meets their requirements and functions as intended.

At Wi4 Corporation, we believe that the most effective way to do this is through software validation. We have extensive experience in performing software validation and have developed a comprehensive and customizable software validation methodology that ensures our clients’ software meets their requirements and functions as intended.

A medical device verification and validation program is a comprehensive process that is designed to ensure that a medical device functions as intended and meets all safety and regulatory requirements. The verification and validation process typically includes the following steps:

  1. Define the product requirements
  2. Design the product to meet the requirements
  3. Test the product design against the requirements (verification)
  4. Manufacture the product and test it against the requirements (validation)
  5. Release the product for use in humans

Medical device design validation is the process of verifying that a medical device meets its intended purpose and function. This process ensures that the device is safe and effective for use in humans.
At Wi4 Corporation, we have a team of experienced professionals who can help you with all aspects of medical device validation, from concept to finished product. We can provide support at every stage of the development process, ensuring that your device meets all regulatory requirements. Contact us today to learn more about our services.

Validation is the process of demonstrating that a medical device or system meets all the requirements specified in the applicable regulations, standards, and specifications.

Achieving validation requires a comprehensive approach that incorporates design controls, risk management, manufacturing controls, and testing. The objective of validation is to ensure that devices are safe and effective when used as intended.

Validation is an important step in bringing a medical device to market. It helps to ensure patient safety and provides assurance that the device will perform as intended under real-world conditions.

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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Medical device software validation

We are one of the best Medical device software validation Solutions provider in the Great Atlanta Region. We have come under top 100 Medical device software validation Solutions companies in USA by multiple rating agencies

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ISO 13485 validation of software

Wi4 is a leading Medical device software validation company in Atlanta having experienced and best medical device software verification validation and compliance. We provide dedicated medical device software verification validation and compliance 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 software verification validation and compliance Solution development agencies in the United States.​