What we can help you with

IEC 62304 is a standard for medical device software. Wi4 Corporation is a leading provider of medical device software. We comply with the IEC 62304 standard and can provide you with the resources and expertise you need to develop medical device software that meets your specific requirements. Contact us today to learn more about our services and how we can help you create compliant medical device software.

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

IEC 62304

At Wi4 Corporation, we are experts in the IEC 62304 medical device classification system. There are distinct classes of medical devices defined in IEC 62304, each with its own unique set of requirements. Class I devices are considered low-risk and require the least amount of controls to be in place. Class II devices are considered higher-risk and require additional controls to be in place. Class III devices are considered the highest risk and require the most stringent controls to be in place.

No, IEC 62304 is not mandatory. However, it is a widely-used and accepted standard for medical device software development.

The Wi4 Corporation is a leading provider of medical device software development services, and we are certified by IEC 62304. We have extensive experience in helping clients meet the stringent safety and quality requirements of the medical device industry. Contact us today to learn more about our services!

IEC 62304 defines the software life cycle requirements for medical device systems. The standard applies to all software used in medical devices, including embedded, standalone, and application software. IEC 62304 was developed by the International Electrotechnical Commission (IEC), a leading international standards organization.

The standard is based on an internationally recognized software development process model known as V-model. The V-model is a robust approach that has been proven successful in many industries.

IEC 62304 divides the software development process into four phases: planning, development, validation, and maintenance. Each phase must be completed before proceeding to the next phase.

The Wi4 Corporation is the largest and most highly respected company in medical device software. They are a global leader in providing software development and regulatory consulting services to the medical device industry. With years of experience, they have helped develop software for some of the most complex devices on the market.

Their team of engineers is highly experienced in safety-critical development, and they have a proven track record in helping companies meet FDA and international regulatory requirements. Their solutions are tailored to each customer’s specific needs, and they work closely with their clients to ensure that their products are safe, reliable, and compliant with all applicable standards.

The latest and most up-to-date version of IEC 62304 is the 3rd edition, which was released in June of 2016. The main changes from the 2nd edition include updates to terminology, clarification on risk management processes and requirements, and the addition of a new product lifecycle extension stage.

IEC 62304 is a standard for medical device software development and is widely recognized as one of the most comprehensive and rigorous standards in this area. It covers all aspects of the software development life cycle, from requirements specification to post-market surveillance.

If you’re looking for an organization that can help you comply with IEC 62304, Wi4 Corporation is one of the leading providers in this area.

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

Featured Insights

[userip_location type="ip"]

[userip_location type="country"]

[userip_location type="city"]

[userip_location type="timezone"]

Send in your queries here to reach out to us!

IEC 62304

Wi4 Corporation is a leader in IEC 62304 compliant software development. We have extensive experience developing software solutions for a wide range of medical devices, from simple single-use devices to complex life-support systems. Our team of experts can help you assess your specific needs and develop a tailor-made solution that meets all the requirements of IEC 62304.

We are on top of Google Search with below keywords: IEC 62304 compliance, iec 62304 medical device software, iec 62304 certification, iec 62304 remodeling, iec 62304, and iso 62304

IEC 62304 Medical Device Software

Wi4 is a leading IEC 62304 medical device software Development company in Atlanta having experienced iec 62304 medical device Software Solution developers. We provide dedicated IEC 62304 Software development 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 iec 62304 medical device Software Solution development agencies in the United States.