medical device software development
At VerveLo, we recognize the importance of software design and development for medical devices. To create safe, FDA-approved Software as a Medical Device (SaMD) and other medical device software solutions, our team blends tried-and-true software architecture with top-notch project management techniques.
Vervelo Provides Medical Device Software
Our specialty at VerveLo is creating specialized medical device software solutions and safe, FDA-approved Software as a Medical Device (SaMD). Our team of professionals is committed to developing cutting-edge, superior software that will increase patient care, expedite clinical procedures, and improve medical device performance.
Medical device software
Class II Medical Devices:
Medium-Risk Solutions for Everyday Healthcare Class II devices play a crucial role in monitoring and managing various health conditions. These medium-risk devices are intended to assist healthcare providers in diagnosing, treating, or monitoring patients in real-time. At VerveLo, we develop FDA-cleared solutions that meet regulatory requirements while enhancing the functionality of devices such as:
\n1. Wearable Glucose Monitors: Continuously track blood glucose levels for diabetic patients and provide real-time alerts to patients and healthcare providers, improving diabetes management.
Class III Medical Devices:
High-Risk Solutions for Critical Healthcare Needs Class III medical devices are high-risk devices that are essential for saving lives or maintaining patients’ health. These devices require the highest level of scrutiny to meet FDA regulations, and VerveLo ensures they are built to provide maximum reliability, safety, and functionality.
Medium-Risk Solutions for Everyday Healthcare Class II devices play a crucial role in monitoring and managing various health conditions. These medium-risk devices are intended to assist healthcare providers in diagnosing, treating, or monitoring patients in real-time. At VerveLo, we develop FDA-cleared solutions that meet regulatory requirements while enhancing the functionality of devices such as:
\n1. Wearable Glucose Monitors: Continuously track blood glucose levels for diabetic patients and provide real-time alerts to patients and healthcare providers, improving diabetes management.
Class III Medical Devices:
High-Risk Solutions for Critical Healthcare Needs Class III medical devices are high-risk devices that are essential for saving lives or maintaining patients’ health. These devices require the highest level of scrutiny to meet FDA regulations, and VerveLo ensures they are built to provide maximum reliability, safety, and functionality.
Key Use Cases for Remote Patient Monitoring and Smart Medical Devices
VerveLo specializes in creating innovative, secure, and compliant medical device solutions for a variety of applications. Our use cases focus on improving patient outcomes and optimizing healthcare delivery, particularly for chronic disease management and remote care.
Medical Devices with Software (SaMD)
At VerveLo, we specialize in Software as a Medical Device (SaMD), providing innovative and secure solutions for a wide range of medical applications. Our SaMD solutions are designed for smartphones, tablets, PCs, laptops, smartwatches, wearable fitness trackers, and smart TVs, enabling healthcare providers and patients to leverage cutting-edge technology for disease management, diagnostics, and treatment planning.
Target Devices for Software as a Medical Device (SaMD)
Our SaMD solutions are designed to work seamlessly across a wide range of devices, making healthcare more accessible and efficient. With our expertise, we ensure that medical software integrates with both everyday consumer devices and specialized medical hardware.
Use Cases for Software as a Medical Device (SaMD)
Our SaMD solutions extend across a variety of use cases, helping healthcare professionals make better decisions, providing personalized patient care, and empowering patients to manage their health more effectively. Below are some of the key use cases for our SaMD solutions:
AI-Based Disease Treatment and Patient Care Planning:
Leveraging artificial intelligence (AI), our SaMD solutions assist healthcare providers in diagnosing and treating diseases more effectively. AI algorithms help analyze patient data, develop personalized treatment plans, and predict disease progression, improving patient outcomes.
Modules for medical device software that are most requested
Mobile app
Access to SaMD data or medical device software while on the go facilitates patient disease management or the work of medical experts.
Platform for the cloud
Devices that are connected to the cloud, including as pacemakers, glucose monitors, and smart inhalers, provide diagnostic, treatment, and patient vital data to the cloud platform for analysis. Management of the linked devices is made possible by cloud platforms (e.g., device failure identification, parameter tuning).
sophisticated analytics
The medical device software employs AI and ML to analyze data from linked devices, identify patient trends, forecast the progression of the condition, flag potentially dangerous symptoms early, evaluate the effectiveness of medications, and more.
IoT-driven tracking of medical devices
Complex medical equipment and devices are tracked to identify their locations, ensure proper device disinfection and sanitation, decrease device search time, and provide remote maintenance.
Real-time health monitoring
The medical device software gathers, saves, and evaluates patient health data (such as blood glucose levels and sleep patterns) in order to automate hospital procedures and encourage individuals to take charge of their own health.
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Our Procedures for Developing Software for Medical Devices
1. Elicitation of needs, collection of requirements, and approval of specifications
In order to develop the software concept and determine and rank the software requirements, we talk about the pertinent demands and the idea of medical device software with important stakeholders on your side. Next, we examine software risks, develop a risk management strategy, and produce a comprehensive specification for medical device software.
2. Software engineering for medical devices
With the help of our dependable and scalable architecture (such as N-tier or SOA), you may add additional modules or device types to your medical device software with little to no rework. Clear module interfaces, system configurability, and effective module encapsulation are all guaranteed by our architects.
3. Software for medical devices: UX/UI design
We map thorough user paths, create user scenarios, and carry out UX research. Regardless of tech proficiency, all age groups can quickly and easily learn medical device software thanks to its sleek user interface.
4. Development of software for medical devices
cross-platform programming to support a variety of OSs.
smooth interaction using FHIR or HL7 v.3 with medical software (EHR, ADT).
5. Assurance of quality
S-SDLC (Secure Software Development Life Cycle) practices from OWASP, which include thorough multi-level quality assurance, are what we use. We carry out frequent code reviews, software validation and verification, and continuous testing throughout the development process in an effort to achieve 100% code coverage.
6. Submission before the market
services for development in accordance with IEC 62304, ISO 13485, and IEC 82304-1.
comprehensive records (such as the Design History File) for CE marking, FDA 510(k) premarket notice, HIPAA compliance audits, etc.
evaluation of HIPAA/GDPR risks.
7. Integration with smart devices (general-purpose, medical, wearable, and non-wearable)
stable communication (for remote patient monitoring, for example) with the IoMT system.
thorough analysis of health data generated by patients and gathered by devices.
8. Support and development of medical device software
We oversee the software’s security and performance, carry out standard software administration duties, and assist in the further development of your medical device software, if necessary.
Applications for Software That Will Gain from
Medical Device Integration
Medical staff apps and RPM apps
Care teams receive alerts in the event of significant changes and have real-time access to automatically collected vital signs of both hospitalized and distant patients.
Applications for telehealth
Based on precise health data gathered by gadgets and sensors, doctors can effectively direct remote therapy.
Apps for managing chronic illnesses
to make it easier for patients to keep an eye on their long-term health (e.g., daily insulin consumption or blood glucose level for diabetic patients).