medical device software development
Medical device software
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:
1. 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.
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 personalised patient care, and empowering patients to manage their health more effectively.
- Such as fractal analysis of malignant lesions, real-time arrhythmia detection, stroke diagnosis via imaging AI, and Propeller Health’s smart inhalers for sensor-driven chronic care monitoring.
Some of the key use cases for our SaMD solutions
AI-Based Disease Treatment and Patient Care Planning with Leveraging artificial intelligence (AI), our SaMD solutions assist healthcare providers in diagnosing and treating diseases more effectively.
AI algorithms help analyze patient data, develop personalised treatment plans, and predict disease progression, improving patient outcomes.
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.
Regulatory Compliance & Safety Frameworks
Ensures medical devices adhere to global standards (FDA, FDA 510(k), ISO 13485, HIPAA, MDR) through embedded compliance workflows, data encryption, and automated risk management protocols.
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
3. Software for medical devices: UX/UI design
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
6. Submission before the market
7. Integration with smart devices (general-purpose, medical, wearable, and non-wearable)
8. Support and development of medical device software
Medical staff apps and RPM apps
Applications for telehealth
Apps for managing chronic illnesses
Pune, Maharashtra, India
What is medical device software development?
What types of medical device software do you develop?
We build a wide range of solutions, including:
- Embedded firmware for Class I/II/III devices
- Wearable device applications
- Diagnostics & monitoring software
- AI/ML-powered imaging & analytics platforms
- Mobile companion apps
IoT integration with cloud-based dashboards
How do you ensure regulatory compliance (FDA, MDR, etc.)?
Our development lifecycle follows IEC 62304-compliant processes with documentation, risk management, and testing frameworks to align with:
- FDA 510(k) and De Novo requirements
- EU MDR and IVDR
- ISO 13485 quality system integration
Cybersecurity standards (e.g., FDA premarket guidance, ISO/IEC 27001)
How long does it take to develop medical device software?
The timeline varies based on device classification, complexity, and regulatory path. A Class I device with embedded software might take 4–6 months.
What is the difference between standalone software and embedded software in medical devices?
- Embedded software is installed directly on a device (e.g., insulin pump firmware).
- Standalone software (SaMD) operates independently, often on mobile/desktop/cloud platforms, and performs clinical functions like diagnosis, monitoring, or recommendations.
Can you assist with FDA or CE mark submission for medical software?
Yes. We provide end-to-end regulatory documentation support, including:
- Design history file (DHF)
- Software requirements specifications (SRS)
- Verification and validation plans
- Risk management files (ISO 14971)
- 510(k), De Novo, or CE technical file preparation
What platforms and technologies do you use?
We work with:
- Embedded C/C++, RTOS, and bare metal systems
- Python, TensorFlow, PyTorch for AI/ML modules
- Bluetooth Low Energy (BLE), Zigbee, MQTT for IoT
- React Native, Flutter for mobile apps
- AWS, Azure, Google Cloud for HIPAA-compliant cloud infrastructure
How do you manage cybersecurity in connected medical devices?
We implement end-to-end cybersecurity measures, including:
- Secure boot and firmware updates
- Data encryption (AES, RSA)
- Authentication & session controls
Compliance with NIST, FDA cybersecurity guidance, and OWASP Top 10