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What we can help you with

We develop software for class 2 and class 3 devices, so you can be sure your product will meet all regulatory requirements. Our team of experts will work with you to ensure your product is high quality when it hits the market.

Embedded Software Development

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

Medical Device

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.

If you are a medical device manufacturer, you know that you need to validate your software in order to meet FDA requirements. But what does that mean, exactly? And how do you go about it? In this blog post, we will discuss the FDA software validation requirements and provide some tips on how to comply with them.

First, let’s define software validation. Software validation is the process of ensuring that a software system meets all the requirements that have been specified for it. This includes functional requirements (e.g., the software must be able to perform certain tasks), as well as non-functional requirements (e.g., the software must be user-friendly).

In order to validate your medical device software, you will need to follow these steps:

• Plan: Define what needs to be validated and how it will be done.

• Execute: Perform the actual validation tests and document the results.

• Evaluate: Analyze the results of the tests and make sure they meet all the requirements.

If you want to le arn more about software validation, we recommend checking out our blog post on the subject. And if you have any questions, feel free to contact us – we’re always happy to help!

As the use of software in medical devices continues to increase, device manufacturers need to be aware of the unique challenges of developing this type of software. One of the most important considerations is patient safety. Unlike most consumer products, medical devices are subject to rigorous safety regulations, and any software errors could have serious consequences. As a result, manufacturers must develop and test their software thoroughly before releasing it.

As the use of software in medical devices continues to increase, device manufacturers need to be aware of the unique challenges of developing this type of software and one of the most important considerations is patient safety. Unlike most consumer products, medical devices are subject to rigorous safety regulations, and any software errors could have serious consequences and As a result, manufacturers must develop and test their software thoroughly before releasing it. Another consideration is cybersecurity. Medical devices are often connected to hospital networks, making them susceptible to cyberattacks. To protect patients’ data and ensure the safety of their devices, manufacturers must implement strong security measures. Finally, manufacturers must also keep up with changing technology. As new software and hardware platforms are developed, they will need to ensure that their devices are compatible with these latest standards. By following these guidelines, manufacturers can ensure that their medical devices are safe, secure, and up-to-date.

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.

The legal compliance requirements for medical device software vary depending on the country in which the software will be used. In the United States, the Food and Drug Administration (FDA) regulates medical device software. The FDA has established various guidelines and regulations that medical device software developers must follow to ensure their products are safe and effective.

In Europe, medical device software is regulated by the European Union (EU) Medical Devices Directive (MDD). The MDD requires that medical device software meet certain safety and performance standards.

Developers of medical device software must comply with all applicable legal requirements to sell their products. Fail ure to comply with these requirements can result in fines, product recalls, and other legal penalties.

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.

The stages of development for medical devices can be broadly divided into four categories:  

  1. Research and feasibility 
  2. Design and development 
  3. Testing and validation 
  4. Commercialization 
  5. Research and feasibility: In this stage, the idea for the device is generated and explored. Feasibility studies are conducted to determine whether the device is physically possible and if it will meet the needs of the target population.
  6. Design and development: Once it has been determined that the device is feasible, work begins on designing and developing it. This stage includes everything from conceptualizing the device to prototyping and testing.
  7. Testing and validation: Once the device has been designed and developed, it must undergo rigorous testing to ensure that it is safe and effective. This stage includes both pre-clinical and clinical trials.
  8. Commercialization: If the device passes all the tests and trials, it is then ready for commercialization. This involves making the device available for purchase by the public.

Medical devices go through a long and complex journey from idea to market. It is important to remember that there is no one-size-fits-all approach to development; each device will have its own unique set of challenges. However, by understanding the general stages of development, you can be better prepared for what lies ahead 

There isn’t necessarily one “standard” for medical device software. Instead, multiple standards may be applicable, depending on the device and software involved.

For example, some common standards for medical device software include requirements from the FDA (USA), ISO 13485 (international), and IEC 62304 (software safety). However, many other standards may apply to a particular device or software.

There isn’t necessarily one “standard” for medical device software. Instead, multiple standards may be applicable, depending on the device and software involved.

For example, some common standards for medical device software include requirements from the FDA (USA), ISO 13485 (international), and IEC 62304 (software safety). However, many other standards may apply to a particular device or software.

It’s import tant to work with a qualified team familiar with the relevant standards for your project. That way, you can ensure that your software meets all the requirements.

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.

Embedded software development is the process of developing software that is used in devices or machines that are not typically thought of as computers. This can include anything from small electronic devices like calculators and washing machines to larger systems like cars and industrial machinery.

The chall enge with embedded software development is that it must be able to work within the limited resources of the target device. This can include factors such as limited memory or processing power, or a need to work within real-time constraints. This means that traditional software development techniques may not be suitable, and specific embedded software development tools and methodologies may need to be used instead.

Embed ded software development can be a complex and challenging process, but it is essential for the creation of many modern devices and systems. By understanding the challenges and using the right tools and methods, it is possible to create high-quality embedded software that meets the needs of both the device and its users.

IEC 62304 is a standard for designing and manufacturing medical device software. It covers the entire product lifecycle, from requirements gathering to maintenance and support.

IEC 62304 is a standard for designing and manufacturing medical device software. It covers the entire product lifecycle, from requirements gathering to maintenance and support.

The standard defines four key process areas:

Requirements management – ensures that all the requirements have been captured and are traceable throughout the project.
Software design – focuses on how the software will meet the requirements. This includes defining interfaces, data structures, and algorithms.
Software implementation – covers coding, testing, and integrating the software components.
Software maintenance – ensuring that changes to the software are made in a controlled way, minimizing the impact on existing functionality.

IEC 62304 is an international standard for the software development of medical device applications. It defines four levels of risks, from level A (lowest risk) to level D (highest risk), and guides how to manage software development at each level.

IEC 62304 is not a prescriptive standard but rather a flexible one that can be adapted to the specific needs of any given project. This flexibility is one of its key strengths, as it allows developers to tailor their processes and practices to the unique risks posed by their particular product.

The stand ard covers all aspects of medical device software development, including requirements gathering, design, testing, validation, verification, configuration management, and more.

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.

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Improved provider productivity

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

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Medical Device Development Services

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

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Medical Device Software Developers

Wi4 is a leading medical device software development company in Atalnta having experienced medical device software developers. We provide dedicated medical device development services including FDA approved solutions, iec 62304 medical device software, and aami tir45 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.

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