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What we can help you with

Medical device software risk management is critical to protect patients and ensure the safety of medical devices. At Wi4 Corporation, we have extensive experience in helping companies manage the risks associated with medical device software. We understand the complex regulatory environment and have the expertise to help you develop a comprehensive risk management program that meets FDA requirements.

Our approach includes a risk assessment of your software development process, identification of potential hazards, and development of mitigation strategies. We also provide training for your team on how to identify and manage risks throughout the software development lifecycle. With our help, you can be confident that your medical device software is safe and reliable.

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

Medical Device Software Risk Management

Wi4 Corporation, a global technology, and services company, specializes in risk control measures for medical device software and our compre hensive software security solutions protect against data breaches, hacking, and malicious code infiltration. With over two decades of experience in the medical device industry, we are experts in mitigating risk and ensuring the safety and security of our customers’ software applications.

At Wi4 Corporation, we understand that protecting patient safety is of paramount importance. Our risk control measures for medical device software provide comprehensive coverage against all manner of threats, from accidental data loss to deliberate cyber-attacks. We work closely with our customers to develop targeted solutions that meet their specific needs and comply with stringent regulatory requirements.

For more information on our risk control measures for medical devices, kindly contact us.

Given the critical role that software plays in modern healthcare, it’s no surprise that medical device software risk management is a major focus for the industry. Risk management is the process of identifying, assessing, and controlling risks to ensure that exposure to hazards is minimized and in the context of medical device software, risk management includes activities like identifying potential hazards associated with the use of a particular software application, assessing the risks posed by those hazards, and implementing controls to mitigate or eliminate those risks.

There are a variety of factors that need to be considered when conducting a medical device software risk assessment.

There are many risks associated with developing and deploying software for medical devices like one key risk is the potential for software errors that could result in patient harm or even death. To mitigate this risk, software developers must adhere to rigorous standards and best practices for development, testing, and validation.

Software risk management for medical devices is a process by which developers identify, assess, and mitigate risks associated with their software development projects. The goal is to ensure that any errors or vulnerabilities in the software do not put patients at undue risk.

Wi4 Corporation recommends the following risk management basic principles for medical device software design:

  1. Establish a clear and concise goal for the software. The goal should be specific, measurable, achievable, relevant, and time-bound.
  2. Define the system requirements for the software. The requirements should be based on the goal of the software and include specifications for features, functions, performance, and interfaces.
  3. Identify and assess risks associated with the development of the software. Risks should be assessed at all stages of development, from requirements gathering through system testing.
  4. Develop a risk management plan to address identified risks. The plan should include specific actions to mitigate each risk and assigned responsibility for implementing those actions


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

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Medical Device Software Risk Management

We are one of the best medical device software risk management Solutions provider in the Great Atlanta Region. We have come under top 100 medical device risk management software Solutions companies in USA by multiple rating agencies

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Medical Device Software Risk

Risk management is a critical component of any medical device software development project. At Wi4, we have developed a robust risk management process that helps our clients ensure the safety and efficacy of their devices.

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 Risk Management Software Solution development agencies in the United States.