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What Sets Us Apart

Developing custom software for medical devices is a complex process that requires a great deal of experience and knowledge. Many companies try to develop their own software, but this can lead to serious security and compliance risks. Wi4 has the experience and knowledge necessary to develop custom medical device software that meets all your needs and requirements. We are experts in HIPAA, device security, and legal compliances, and our software is always user-friendly. 

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

SaMD

Yes, the software can be a medical device. The Food and Drug Administration (FDA) has defined medical devices as “instruments, machines, implants, in vitro reagents, and other similar or related articles, including parts or accessories,” which are “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.” In other words, as long as a software product meets the definition of a medical device, it can be regulated by the FDA.

Yes, the software can be a medical device. The Food and Drug Administration (FDA) has defined medical devices as “instruments, machines, implants, in vitro reagents, and other similar or related articles, including parts or accessories,” which are “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.” In other words, as long as a software product meets the definition of a medical device, it can be regulated by the FDA.

There is no simple answer to this question as it depends on various factors, such as the intended use of the software, whether it is stand-alone or part of a system, etc. In general, however, software used for medical purposes (e.g., to diagnose or treat a patient) is considered a medical device and subject to the Medical Device Regulation (MDR). Generally speaking, the software is not considered a medical device, but there are some exceptions, for example, software that is used to generate results from medical images is considered a medical device under the European Union’s Medical Devices Directive (MDR).

There is no simple answer to this question as it depends on various factors, such as the intended use of the software, whether it is stand-alone or part of a system, etc. In general, however, software used for medical purposes (e.g., to diagnose or treat a patient) is considered a medical device and subject to the Medical Device Regulation (MDR). Generally speaking, the software is not considered a medical device, but there are some exceptions, for example, software that is used to generate results from medical images is considered a medical device under the European Union’s Medical Devices Directive (MDR).

Medical devices come in all shapes and sizes, from simple tongue depressors to life-saving implants. But what about software? The software can be crucial to the functioning of medical devices and is regulated as a medical device itself when used for patient care. This is called software as a medical device, or SaMD. SaMD can be used for various purposes, from diagnosis and treatment to patient monitoring and health management. It can be used alone or in conjunction with hardware and can be implemented in various ways, from wearable devices to apps. Due to the nature of software, SaMD is constantly evolving, and the FDA must keep up with the latest technologies.

Medical devices come in all shapes and sizes, from simple tongue depressors to life-saving implants. But what about software? The software can be crucial to the functioning of medical devices and is regulated as a medical device itself when used for patient care. This is called software as a medical device, or SaMD. SaMD can be used for various purposes, from diagnosis and treatment to patient monitoring and health management. It can be used alone or in conjunction with hardware and can be implemented in various ways, from wearable devices to apps. Due to the nature of software, SaMD is constantly evolving, and the FDA must keep up with the latest technologies.

Medical devices are becoming increasingly complex, and as a result, the software that controls them is also becoming more complex. This has led to development of a new category of medical devices, known as software as a medical device (SaMD). SaMD is a type of medical device that is controlled by software. This can include pacemakers, implantable cardioverter defibrillators (ICDs), blood pressure monitors, and glucose meters. The software that controls a SaMD is considered part of the device, and as such, it must meet the same safety and efficacy requirements as the device itself.

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Our Impact

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

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Featured Insights

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    Software as a medical device company

    We are one of the best SaMD service provider in the Great Atlanta Region. We have come under top 100 Software as a medical device development companies in USA by multiple rating agencies,

    We are on top of Google Search with below keywords: software as a medical device company, medical device software companies, fda guidance software as a medical device, quality management software medical device, fda guidance software medical device

    Medical device software companies

    Wi4 is a leading software as a medical device company in the Atalnta having experienced SaMD developers. We provide dedicated SaMD services including FDA approved solutions to our customers which leads to a 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 development agencies in the United States.