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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.

Category: 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.

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).

Category: Medical Device

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).

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.

Category: Medical Device

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 learn 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!

What are some tips for complying with FDA software validation requirements?

Here are a few tips that will help you comply with FDA software validation requirements:

• Make sure you have a clear understanding of all the requirements before you start.

• Plan your validation tests carefully and execute them thoroughly.

• Document everything – this will be important if you ever need to show the FDA your process.

• Use a reputable software testing company like Wi4 to help you with the process.

Following these tips will help you ensure that your software validation process is up to FDA standards. And if you ever have any questions, our team at Wi4 is always here to help. Contact us today to learn more!

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.

Category: Medical Device

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. 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.

Category: Medical Device

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. Failure 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.

Category: Medical Device

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.

Category: Medical Device

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 important 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.

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.

Category: Medical Device

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.

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.

Category: Medical Device

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 challenge 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. 

Embedded 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.

Category: Medical Device

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:

  1.  Requirements management – ensures that all the requirements have been captured and are traceable throughout the project.
  2.  Software design – focuses on how the software will meet the requirements. This includes defining interfaces, data structures, and algorithms.
  3.  Software implementation – covers coding, testing, and integrating the software components.
  4.  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 standard covers all aspects of medical device software development, including requirements gathering, design, testing, validation, verification, configuration management, and more.

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    Medical Device Development Services

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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.