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Medical Device Software Development
EffectiveSoft specializes in developing custom medical device software that helps healthcare organizations bring innovative technologies to market quickly and confidently, without compromising on safety or performance.
Clutch proven
With over 19 years of experience delivering high-quality healthcare solutions, EffectiveSoft is a trusted partner in the medical industry. The company has earned multiple recognitions from Clutch, including awards for Top Software Developers and Top IT Services Company.
Services
Our medical device software development capabilities
User-centered interfaces for medical diagnostic devices
The EffectiveSoft team creates intelligent, intuitive experiences that connect medical diagnostic hardware with its end users: clinicians, lab technicians, and patients. By integrating device communication protocols, custom user interface/user experience (UI/UX) design, and intuitive, user-centered workflows, we deliver reliable and adaptable cross-platform interfaces. We engineer experiences that support and enhance existing business workflows, ensuring seamless integration and long-term usability.
Embedded software for medical devices
EffectiveSoft develops software that powers medical devices, including diagnostic equipment, patient monitoring systems, and infusion pumps, ensuring they operate accurately, securely, and reliably. Our engineering approach is fully aligned with ISO/IEC 27001 and IEC 62304, following best practices in medical software development. Our knowledge of regulatory requirements and quality frameworks enables us to integrate smoothly with required quality assurance (QA) processes, helping support efficient compliance and reduce overall effort.
Software as a medical device
We specialize in developing software as a medical device (SaMD)—stand-alone software solutions for various medical purposes, such as diagnosis, treatment, and patient monitoring. Our team brings extensive expertise across all IEC 62304 software safety classes (A, B, and C). With a transparent, risk-aware development approach, we proactively mitigate risks at every stage, from design and implementation to validation, ensuring compliance, safety, and long-term reliability.
Solutions
Tailored solutions for medical devices
We provide medical device software design and development services following industry standards.
Our custom medical device application development adheres to the DICOM standard, enabling the reading and analysis of various types of medical images (MRI, CT, PET, etc.). We build encoders, medical imaging and visualization software, and 3D simulation apps to help medical professionals make accurate diagnoses.
We integrate custom Internet of Medical Things (IoMT) solutions with wearable health devices that can track chronic conditions, facilitate early diagnosis of numerous diseases, and assist with elder care. We create custom applications for ECG, blood pressure and glucose monitors, biosensors, fitness apps for sport devices, as well as software for health watches.
EffectiveSoft builds custom software that complements various diagnostic hardware products used in dental procedures, such as early dental caries detection, periodontal probing, and dental restorations.
Our expertise in ophthalmology device app development enables us to provide medical device software solutions that accompany a wide range of ophthalmic equipment: autorefractors, keratometers, optometers, and other devices used in diagnosis, therapy, and surgery.
We help medical device providers implement telesurgery technology by developing custom medical device applications for surgical robots, laparoscopes, and other instruments. Our apps ensure high accuracy and provide a high-definition 3D vision to improve surgical outcomes.
Our medical device software development company specializes in custom Internet of Things (IoT) apps for trauma and orthopedic departments. These solutions enable precise tracking of patient positioning during surgeries and extension procedures (such as spine extension), while also enhancing measurement accuracy throughout orthopedic operations.
Modules
Core technology modules for medical device software
Cloud infrastructure
Cloud-connected medical devices transmit vital patient, diagnostic, and treatment data to the cloud platform for further processing and analysis.
IoT connectivity
With the help of the IoT, medical devices are tracked to detect assets, reduce device search time, ensure proper disinfection and sanitization, and provide remote maintenance.
Mobile apps provide instant access to medical device software, facilitating the work of medical professionals and improving patient care.
Real-time monitoring
By gathering, storing, and processing patient health data (sleep, glucose, blood pressure, etc.), this module allows for real-time automation of medical facility workflows, while motivating patients to take better care of their own health.
Using artificial intelligence (AI) and machine learning (ML), this module leverages data from medical devices to predict disease progression, detect early warning signs, evaluate treatment effectiveness, and more.
We created a solution that enables fast PCR testing outside of healthcare settings, delivering accurate and reliable results.
Software solution for analyzing, transmitting, and viewing medical imaging data in the DICOM format.
As a part of the innovative optical-scanning diagnostic platform designed for assessment of biomechanical properties of the eye.
The software we developed allows dental clinicians and hygienists to diagnose and treat periodontal diseases.
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Intelligent medical device software with AI/ML
Data interpretation
Powered by AI subsets like natural language processing (NLP) and computer vision, medical device software solutions translate raw data—from unstructured text and speech to images and sensor readings—into actionable insights. Our medical device software developers design and integrate these capabilities to enhance disease detection and diagnosis and facilitate more informed decision-making.
Predictive intelligence
AI and ML algorithms in medical device software engineering enable powerful predictive analytics. Our developers build and integrate predictive models that analyze historical and real-time data to forecast patient risks, device performance, and more. By embedding these capabilities, we help healthcare organizations improve patient results and operational efficiency.
Workflow enhancements
By applying AI/ML models in medical device software development, we help healthcare organizations automate repetitive tasks, streamline clinical processes, and support decision-making with real-time insights. Our engineers design solutions that follow industry standards such as HL7, FHIR, and DICOM, ensuring secure, efficient operation with reduced clinician workload and minimal errors.
Personalized care
AI/ML-powered personalized care allows medical device software to adapt to each patient’s unique case. Our team integrates intelligent features that analyze patient-specific data to offer tailored treatment plans with medication adjustments, support timely interventions, or even remote monitoring and guidance, significantly enhancing health outcomes.
What about you?
Want to accelerate innovation without risking compliance? EffectiveSoft develops secure, reliable medical device software tailored to your needs.
Integrations
Integration services
By integrating medical devices with electronic health records/electronic medical records (EHR/EMR) systems, existing infrastructure can be connected to smart vital sign monitors and other medical devices. This allows healthcare providers to access real-time data from a single location and deliver high-quality and timely care to patients.
Integrating medical devices with telemedicine solutions facilitates smooth communication between medical staff and patients, regardless of location. This allows doctors to receive the patient’s health indicators in real time and conduct full-scale consultations, improving patient outcomes.
Hospital management systems
Integration with hospital management systems allows the hospital to function as a unified entity, with all devices interconnected to support seamless patient logistics and improved care. This integration also helps reduce risks associated with human error.
Process
Our medical device software development process
Requirement gathering
Our team works in close cooperation with clients to elicit their needs, gather requirements, develop a concept, and outline detailed specifications for the future solution.
Design and prototyping
At this stage, our medical device app developers create technical documentation and a project road map, while our design team works on UX and UI.
Software development
Once the project requirements are established and the UX/UI design is complete, our software developers start crafting the medical device software. We use the Agile approach for project development.
Software testing
We conduct continuous quality testing of the system after each iteration to ensure proper functionality and compliance with all relevant medical standards and regulations.
Support and maintenance
We provide support and maintenance services under a service level agreement to ensure stable system operation during deployment. In collaboration with the client, we define the scope of work that will be performed regularly after development, including 24/7 technical support, customer service, backup and security audits, performance monitoring, migration to the cloud, and product updates.
Who we serve
Trusted by healthcare leaders across the industry
Laboratories
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Blood banks
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Hospitals
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Research centers
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Medical device manufacturers
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Pharmaceutical companies
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Imaging and radiology centers
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Telehealth and remote patient monitoring providers
Compliance
Our compliance
As a reputable vendor, we guarantee that our solutions comply with industry standards and regulations, including
- GDPR
- CMMI
- HIPAA
- CCPA
- ISO 27001:2022
Why us
Why choose EffectiveSoft?
Domain expertise
For over 19 years, EffectiveSoft has been delivering reliable and secure custom solutions across various healthcare sectors. Our engineers are well-versed in ICD-10 and CPT coding systems and have deep expertise in healthcare data standards, including FHIR and HL7 protocols. We ensure full compliance with industry regulations such as HIPAA and ISO/IEC 27001:2022.
Rigorous testing
Our cross-functional team aligns with the V-model, ensuring each development phase (from requirements to implementation) is directly validated through corresponding test activities. This structured approach enhances traceability, early defect detection, and regulatory compliance, delivering reliable, high-quality medical device software with a strong focus on safety and performance.
Technical proficiency
EffectiveSoft prioritizes continuous improvement and learning, encouraging our team to advance their competencies and skills, especially in AI and cloud technologies. Our specialists hold top certifications, including AWS Certified Developer (Associate), AWS Certified Solution Architect (Associate), Azure Solutions Architect, Azure AI Engineer, and SAFe (6.0).
Client-centric approach
We approach every project by getting to the root of your challenges, pain points, and objectives. Working closely with you from the start, our team ensures you are informed and involved at every stage. We remain flexible throughout the process, ready to adjust the project scope, timeline, or technologies as your needs evolve.
Continuous support
After launch, you are not left on your own. We continue monitoring the solution for performance and security vulnerabilities, resolving any issues promptly before they affect users. Our team ensures the system remains stable and functional over time, rolls out new features based on feedback and requirements, and supports the evolution of the software as your business scales.
Focus on design and usability
In medical device software, intuitive navigation is essential. Our UX/UI team brings a deep understanding of user behavior and the unique demands of the healthcare industry to design exceptional experiences. Through surveys and user feedback, we ensure every solution meets your expectations and aligns with your workflows.
F.A.Q. about medical device software development services
Medical device software design is the process of implementing and validating software that is embedded within a medical device or used as a stand-alone solution (SaMD). The development process involves requirement gathering and engineering, system architecture, detailed design, implementation, validation, and maintenance. As healthcare software development is a highly regulated process, these solutions are designed in compliance with regulatory requirements and standards.
This software offers several business advantages for diagnostics and patient monitoring, especially if implemented with AI. Medical device software reduces human errors and enhances diagnostic accuracy, cuts costs, boosts operational efficiency, improves patient outcomes, and more.
A wide range of technical solutions and tools can be used to develop software for medical devices, with the final tech stack chosen based on the specific needs of your project.
At EffectiveSoft, we strictly adhere to industry regulations and standards to ensure the safety, quality, and compliance of medical device software. These include IEC 62304, HIPAA, EU Medical Device Regulation, FDA, and other region- and project-specific standards as required.
Yes, development can start without the physical device by using a simulation of the medical device. This allows us to build and test medical device software without needing the actual hardware.
To ensure seamless interoperability between medical device software and existing healthcare systems like EHRs, our medical device software developers follow industry best practices and strategies. Our team adopts standards-based communication (HL7, FHIR, DICOM, etc.), implements robust data mapping, conducts rigorous testing and validation, ensures compliance with regulatory standards for protected health information, and integrates the system seamlessly into clinical workflows.
For medical device software, usability and accessibility are critical because they directly affect patient safety, clinician efficiency, and compliance. At EffectiveSoft, we believe that these aspects should be addressed not only at the design stage but throughout the entire development process. We implement thorough user research, work out different use scenarios, and validate design choices through feedback. Our team ensures simplicity and consistency of UI and designs solutions to minimize user errors. To strengthen accessibility, we follow Web Content Accessibility Guidelines (WCAG) and industry best practices.
Yes, EffectiveSoft engineers integrate AI/ML into medical device software to support applications such as diagnostics assistance, predictive analytics, image recognition, patient monitoring, and decision-support systems. Our intelligent systems are validated through a combination of rigorous testing and compliance with industry regulations to ensure patient safety and efficient model performance.
The cost of medical device software development depends on the project’s scope, team size, and security requirements. Want more information on your specific requirements? Contact our team for a project estimate.
EffectiveSoft provides both staff augmentation services and dedicated software development teams. Depending on your company’s requirements and needs, we offer targeted services, such as consulting, business analysis, design, development, quality assurance, data analytics, and end-to-end software development. Contact our team to learn more about our approach.
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