Intellias Digital Healthcare Solutions→Medical Device Software Development

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Medical Device Software Development

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We build medical device software for healthcare providers and medical device companies. The pillars of our work are compliance, innovation and reliability.

From improving patient outcomes to streamlining operations, the impact of digital health technologies is profound and far-reaching. Innovations like robotics, artificial intelligence and telehealth attract significant investment and play a key role in advancing digital healthcare. As more hospitals and healthcare facilities pursue digital transformation, the global digital health market is expected to exceed $270 billion by 2028.

Intellias offers medical device software development services for healthcare providers and medical device companies. From safe and compliant medical systems and diagnostic tools to payment platforms and regulatory compliance strategies, we enable medical professionals to provide the best patient care and ensure the best possible outcomes.

Our services

Our medical device software engineering teams deliver software for hospital systems, remote patient monitoring platforms, wearables, and other medical applications.

We create custom medical device software in compliance with the latest regulations to enable real-time monitoring and management of medical device software solutions, collect and analyze health data, and allow for integration with other peripheral smart devices within healthcare systems.

Embedded software enables medical devices to operate accurately and securely. We develop software for Class II and Class III medical devices, including wearable and implanted devices:

Class II devices – medium-risk medical devices, such as CT scanners, wearable glucose monitors, blood pressure monitors and wearable ECG sensors
Class III devices – high-risk medical devices, such as implantable nerve stimulators, cardiac ablation systems and neuromodulation therapy

Our medical device software solutions assist medical professionals in carrying out critical tasks such as making diagnoses, planning treatment, viewing and recognizing images, and monitoring health conditions. SaMD solutions are not considered hardware medical devices.
Devices that can run SaMD solutions include:

Smartphones and tablets
PCs and laptops
Smartwatches and wearable fitness trackers
Smart TVs

Our capabilities

Mobile apps

Medical device app development integrated with software for medical devices enables real-time monitoring, data analysis and individualized therapy modifications. Users can easily access vital signs, medication schedules and treatment progress, as well as communicate with practitioners in real time.

Cloud platform

Cloud-based platforms enable integration of large amounts of data from disparate sources so that medical practitioners can get meaningful insights into patients’ health. Such platforms can also detect device issues quickly and enable remote configuration when necessary.

Advanced analytics

Predictive analytics with data from connected devices allows for identification of patient trends and forecasting of illnesses with exceptional precision. Such analysis can recognize early-stage risks, allowing for prompt interventions to improve patient outcomes.

IoT-based medical device tracking

Integrating complex medical equipment and devices with IoT technology enables real-time monitoring of both device location and sanitation status. Additionally, the ability to perform remote maintenance allows technical teams to identify issues, perform upgrades, and carry out repairs from anywhere with greater efficiency.

Real-time monitoring

Integrating medical equipment software with remote patient monitoring systems enhances clinical decision-making with data-driven insights while enabling patients to easily access user-friendly interfaces and data visualizations.

Who we serve:

Laboratories

Blood banks

Medical device manufacturers

Hospitals

Pharmaceutical companies

Research centers

Areas of application

Telemedicine and remote patient monitoring

Remote patient monitoring
Real-time diagnostics
Prescription management
Virtual health checks

Digital therapeutics and patient engagement

Chronic disease management
Behavioral modifications, such as gamification to encourage healthy behaviors
Treatment adherence and support
Post-surgical recovery

EHR/EMR systems and health information exchange

Centralized patient data access
Improved diagnosis and treatment
Interoperability between different healthcare institutions
Automation of administrative tasks

AI-driven healthcare solutions

Clinical decision support
Predictive health solutions
Natural language processing for medical text
Medical image analysis of X-rays, MRIs, CT scans
and ultrasounds

Regulatory compliance:

HIPAA compliance
FDA approval
GDPR compliance
ISO 13485
21 CFR Part 820
CE marking
Patient health information (PHI)

Cybersecurity:

Data encryption
Secure access control
Regular security audits and penetration testing
Data backup and disaster recovery
Incident response plans
Software updates and patching
Data minimization
Secure software development lifecycle
NIST
CISA

What we help you achieve

Accuracy and precision

Our software helps improve the accuracy of medical devices by processing large amounts of data quickly and with high precision, reducing human error.

Remote monitoring
and telemedicine

Medical device software enables remote monitoring of patients via connected medical devices. This allows healthcare professionals to track patient data from a distance, reducing the need for frequent hospital visits while still providing timely interventions when necessary.

Regulatory compliance

Medical device software ensures that devices adhere to rigorous industry standards and regulatory requirements (such as FDA and CE marking requirements). Software features can include compliance with medical standards, documentation, and audit trails, which streamline the approval and monitoring process.

Patient safety and
risk management

Medical device software helps mitigate risks associated with medical devices by incorporating safety features such as alerts, automated diagnostics and fail-safe mechanisms.

Cost reduction

Medical device software helps reduce healthcare costs by improving the efficiency of devices and enabling remote care. Software-driven solutions can optimize resource allocation, reduce the need for hospital readmissions and support the efficient use of equipment and personnel.

Usability

Medical device software is designed to provide intuitive, easy-to-use interfaces for both healthcare professionals and patients that ensure quick adoption and correct use, which is critical in high-pressure medical environments.

Clear outcomes: Our clients' stories

Enterprise-level Platform for Risk
Assessment in Healthcare

For a leading insurance provider, we developed a medical risk assessment portal based on a dynamic neural network.

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Collaborative Maternity Platform
for Personalized Health Guidance

We worked with a government software provider to develop a maternity application that guides expectant mothers through all stages of pregnancy and supports them and their children afterwards.

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E-Referral & E-Request
Healthcare Platform

We automated surgical booking and wait time tracking with an e-referral and e-request platform for a Canadian healthcare provider.

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Mammography Solution
for PACS Workstations

For a German medical imaging company, we re-engineered a leading mammography station to enhance performance and system scalability.

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Development of PFA Device Firmware:
Safe, Effective, and Compliant

We developed firmware for a proprietary pulsed field ablation device that helped facilitate FDA approval for a global medical device provider.

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Medical App Development to Benefit
Practitioners and Individuals

During the pandemic, we developed apps for both patients and physicians as part of a countrywide digital transformation in medical reform.

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Your questions answered

Medical device software is regulated by health authorities such as the FDA in the US, the EMA in Europe, and other national regulatory bodies. These agencies ensure that software complies with stringent standards for safety, effectiveness and security.

Our developers follow rigorous testing and software documentation procedures, including validation and verification, to ensure software performs as intended. This includes clinical trials, risk management assessments and continuous post-market surveillance to monitor real-world performance and safety.

Software as a medical device (SaMD) is standalone software intended for medical purposes (such as diagnostic or therapeutic). Software used in a medical device, on the other hand, is software embedded in or integral to a physical device, like software in a pacemaker or insulin pump.

Software updates for medical devices are carefully controlled and in many cases must go through regulatory review. Updates are typically released to fix bugs, enhance functionality or address safety issues. They must be thoroughly tested, documented and approved before deployment to ensure patient safety.