Software used by 18 states to enhance revenues and reduced time to pay to members of Ticket to Work program.
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
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 medi cal device industry.
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 maint enance. 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 comp liant with all applicable stan dards.
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 lea ding providers in this area.
We have partnered with Federal and State agencies, academia, tech startups, and well-known organizations – positively impacting over a billion lives
With the implementation of Mirth Connect based customized HL7 interfaces, the tedious manual works of message submission