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Medical Device Software Development Services

Computools delivers medical device software development services for healthcare providers, and medical device manufacturers. From medical device prototyping to FDA approval consulting our solutions help bring innovative health technologies to life improving patient outcomes and ensuring compliance

45%

FASTER DEVICE INTEGRATION AND DEPLOYMENT

Achieved through custom firmware development, real-time OS integration, and seamless interoperability with hospital IT systems and cloud platforms.

55%

LOWER MAINTENANCE AND SUPPORT COSTS

Enabled by remote diagnostics, over-the-air (OTA) updates, and predictive maintenance features built into embedded software.

250+

EXPERTS ON BOARD

100% of our MedTech clients rely on our expertise in embedded software, device connectivity, and global compliance standards.

10+

SUCCESSFUL MEDICAL DEVICE PROJECTS

Delivered software for imaging systems, wearable monitors, diagnostic equipment, and surgical devices for manufacturers and digital health innovators worldwide.

We are just as good as our clients say we are because their success is the true measure of ours.

4.9 on Clutch

101 reviews

SOLVING CRITICAL CHALLENGES IN THE MEDICAL DEVICE INDUSTRY WITH CUSTOM SOFTWARE

Key Challenges in the Medical Device Industry

• Navigating strict and constantly evolving regulatory requirements (FDA, MDR, ISO 13485)
• Prolonged time-to-market due to complex development and testing cycles
• Integrating hardware, firmware, and cloud platforms seamlessly
• Ensuring real-time data exchange with hospital IT systems and EHR platforms
• Guaranteeing cybersecurity and patient data protection across connected devices
• Difficulty scaling and updating embedded systems post-deployment
• High maintenance and support costs due to lack of remote diagnostics
• Inconsistent UX across clinician and patient-facing applications
• Lack of analytics for device performance, usage, and patient outcomes
• Delays in clinical validation due to disconnected software-hardware workflows

Custom Software Solutions by Computools

01. Regulatory-Compliant Embedded Software Development

02. Real-Time OS and Firmware Engineering

03. Device-to-Cloud Integration

04. Interoperability with EHR and Hospital IT Systems

05. Cybersecurity for Connected Medical Devices

06. Remote Diagnostics and OTA Updates

07. UX/UI Design for Clinical and Patient Interfaces

08. Device Performance and Outcome Analytics

09. Clinical Trial Software Support

10. Full Lifecycle Software-Hardware Integration

Computools develops embedded software that adheres to FDA, MDR, IEC 62304, and ISO 13485 standards, enabling safe and certifiable device functionality.
Our clients reduce approval delays by up to 35% through documentation-ready architecture.

We build secure, high-performance firmware and RTOS layers optimized for low-latency device operation and hardware integration.
Deployments report 45% faster device responsiveness and stability.

Our team connects medical devices with cloud platforms, mobile apps, and hospital systems to enable real-time monitoring, alerts, and control.
Clients accelerate connectivity deployments by 40% with our prebuilt interoperability modules.

We enable data exchange through HL7, FHIR, and DICOM integration, supporting hospital workflows and patient records synchronization.
Projects show 30–50% fewer integration issues with certified adapters and APIs.

Computools applies security-by-design principles, including encryption, access control, and threat detection, to safeguard patient data and system integrity.
Our clients experience a 70% reduction in security incidents across cloud and embedded layers.

We implement over-the-air (OTA) update functionality, remote device monitoring, and predictive maintenance to reduce support costs.
Medical device firms report 55% lower maintenance expenses post-deployment.

Our UX team creates intuitive, accessible interfaces that meet both clinical efficiency and patient usability requirements.
Enhanced designs improve clinician adoption and reduce onboarding time by 25–40%.

We build analytics dashboards to track real-world device usage, detect anomalies, and correlate product performance with patient outcomes.
Clients use our analytics to optimize product iterations and demonstrate clinical value.

We engineer digital solutions that support device validation workflows, data capture, and compliance tracking for clinical studies.
Our platforms reduce time-to-validation by streamlining protocol adherence and data integrity.

Computools supports the full device lifecycle, from prototyping and software simulation to post-market monitoring, with integrated hardware-software collaboration.
Clients shorten development timelines by 30% through unified workflows.

Modernize your medical devices. Unlock ROI with a quote!

Oleg Svet

Chief Delivery Officer

Medical Device Software Development Services We Deliver

01. Medical Device Prototyping Services

Computools utilizes advanced tools like 3D printers, CNC milling machines, and laser systems to prototype functional physical models of your medical device, enabling rapid visualization, validation, and early-stage testing.

02. CAD Design Development for Medical Devices

We create CAD-based designs that fully comply with ISO 13485:2016 and AIMD (Active Implantable Medical Device) standards, ensuring regulatory alignment and design-for-manufacturing efficiency from the outset.

03. Contract Manufacturing for Class I and Class II Medical Devices

Our team manages end-to-end contract manufacturing of Class I and Class II medical and wellness devices under GMP protocols, ensuring traceability, quality assurance, and regulatory compliance at every step.

04. Embedded Software Development for Medical Devices

We specialize in embedded software development using an ISO 13485-certified risk management framework, guaranteeing safety, reliability, and performance in critical medical device environments.

05. Linux and Android OS Optimization for Embedded Healthcare Devices

Computools adapts and optimizes Linux and Android OS for embedded medical systems, enhancing security, speed, and compliance while accelerating time-to-market.

06. FDA Approval Consulting for Medical Devices

We guide clients through FDA approval processes and assist with HCPCS and CPT certification, helping your medical solution meet U.S. regulatory requirements with confidence.

07. Quality Management System Setup for Medical Device Companies

Computools helps you establish a robust Quality Management System aligned with global regulatory standards, enabling efficient development, documentation, and ongoing audit readiness.

08. State Grant Assistance for Medical Device Clinical Trials

We support innovators in securing state-funded grants for clinical trials, helping accelerate product development and reduce financial barriers to market entry.

GET YOUR CUSTOM BUSINESS SOFTWARE SOLUTION DELIVERED UP TO 18X FASTER. READ HOW →

Start your medical device project with us.

CHOOSE HOW YOU WORK WITH US

Consulting

Our IT consulting services help businesses decide where technology, AI, and automation can create measurable value, modernize critical systems, and turn transformation priorities into an actionable roadmap.

Software Engineering

We deliver custom software development for complex business environments, combining AI, data, cloud, and modern engineering practices with seamless integration into existing systems to reduce operating costs, improve performance, and increase delivery capacity.

Dedicated Teams

Our dedicated development teams add software, cloud, data, and AI expertise where internal capacity is limited, helping businesses move priority initiatives forward without slowing core operations.

CX Strategy & Design

We redesign user and customer journeys to remove friction, improve adoption, and make digital products and workflows easier to use and scale.

Process Automation

We automate repetitive workflows, connect disconnected steps, and reduce manual work, errors, and process delays across business operations.

Software Modernization

We modernize legacy software, architecture, data, APIs, integrations, and interfaces to reduce technical debt and make critical systems easier to evolve, integrate, and scale.

EXPERTISE ACROSS THE MEDICAL DEVICE TECH ECOSYSTEM

01 / 05

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Testimonials

DISCOVER WHY CLIENTS TRUST COMPUTOOLS

5.0

Verified by Clutch

They made everything easy for both patients and our team to use.

Paul Flynn

Founder, Harbor

Feedback summary

Computools has successfully turned the client's idea into a functional app that end users enjoy. The app runs smoothly and makes the client's staff's job easier. The team is easy to work with and puts a lot of thought into the app's design and functionality. They also keep the client updated.

Country

Scotland

Type

Mobile App

Duration

Ongoing

Team Size

6-10 Specialists

Industry

Healthcare

Tech stack

Flutter Java Spring

Read full review →

5.0

Verified by Clutch

Their strong domain expertise clearly sets them apart.

Dr Kathryn Oakland

Medical Director - Clinical Service Lines, HCA Healthcare UK

Feedback summary

Computools has delivered a reliable computer vision engine that integrates into the radiology workflow and assists clinicians with structured image analysis. The team demonstrates strong domain expertise and provides transparent project management that aligns with regulatory checkpoints.

Country

United Kingdom

Type

Web Platform

Duration

Ongoing

Team Size

6-10 Specialists

Industry

Healthcare

Tech stack

Java JPA Servlets jQuery AWS

Read full review →

5.0

Verified by Clutch

Their disciplined approach to privacy and data handling was particularly impressive.

Gil Davide

Digital Health Services Europe & Country Manager, DocMorris

Feedback summary

Computools delivered a stable, compliant teletherapy platform supporting both therapists and patients. The platform consolidated core practice management features into a single environment, improving the client's operational efficiency while maintaining data privacy standards.

Country

Portugal

Type

Web Platform

Duration

12 months

Team Size

6-10 Specialists

Industry

Healthcare

Tech stack

Node.js React PostgreSQL

Read full review →

5.0

Verified by Clutch

Their team demonstrated exceptional skill in transforming complex weather and risk data into practical insights.

Julian Wann

Director Global Freight & Logistics Procurement, AstraZeneca

Feedback summary

The platform improved early identification of weather-related risks and reduced the need for last-minute route adjustments. Computools excelled at transforming weather and risk data into practical insights. The team followed an Agile delivery approach and communicates well.

Country

United Kingdom

Type

Web Platform

Duration

12 months

Team Size

6-10 Specialists

Industry

Healthcare

Tech stack

Node.js React PostgreSQL

Read full review →

5.0

Verified by Clutch

“Computools predicted all possible points of our business growth and implemented them into the project.”

Dr. Bert Carl Schindler

Regional Manager of Business Area, DEIN DENTAL

Feedback summary

Computools' understanding of the client's business processes and ready solution has reduced all industry risks for the client. The team has delivered on time and communicated well through online meetings and emails. The team has predicted all possible points of the client's business growth.

Country

Germany

Type

Web Platform

Duration

Ongoing

Team Size

6-10 Specialists

Industry

Healthcare

Tech stack

Java JPA Servlets jQuery AWS

Read full review → Case study →

5.0

Verified by Clutch

“The most noteworthy value that stood out was their exceptional experience in developing AI software solutions.”

Aaron Thompson

Program & Project Manager, NextCare Health Conference

Feedback summary

Computools' work has allowed the client's medical staff to focus on patient care rather than spending time on the platform. The team has conducted the project using agile methodology and communicated via email. Their exceptional experience in developing AI software solutions is impressive.

Country

USA

Type

Web Platform

Duration

Ongoing

Team Size

6-10 Specialists

Industry

Healthcare

Tech stack

.NET C# ASP.NET MVC AZURE ANGULAR

Read full review → Case study →

5.0

Verified by Clutch

“Computools offered non-standard solutions and maximized their investment in our business success.“

Samuel Ok

Senior Product Manager, Aya Healthcare

Feedback summary

Computools has delivered a fully functional system that meets regulatory requirements, enabling the client to secure funding for clinical trials. The team uses agile methodologies, communicates actively, and is timely, ensuring an efficient workflow. Their innovative solutions set them apart.

Country

USA

Type

Web System

Duration

Ongoing

Team Size

6-10 Specialists

Industry

Healthcare

Tech stack

Node.js NestJS PostgreSQL React WebSocket Biometric SDK

Read full review →

5.0

Verified by Clutch

“They were professional, adapted to our short-notice needs, documented everything, and were transparent.”

Ben James

CEO, Hunter Healthcare

Feedback summary

Computools successfully delivered an app that aligned with the client's requirements. The team delivered the project on time and within budget, allowing for a smooth workflow. Above all, they were professional, adaptable, transparent, detail-oriented, and resourceful throughout the process.

Country

United Kingdom

Type

Mobile App

Duration

12 months

Team Size

2-5 Specialists

Industry

Healthcare

Tech stack

iOS Android Kotlin Swift Firebase REST API GitHub Bitrise

Read full review →

5.0

Verified by Clutch

“Thanks to Computools, we have seen a 15% growth in sales and a 40% boost in user satisfaction. Our image management has become more efficient, and our diagnostic capabilities have improved. Overall, the team has delivered a high-quality solution that meets our requirements.”

Quamil Woods

Paralegal

Feedback summary

Thanks to Computools, the client has seen a 15% growth in sales and a 40% boost in user satisfaction. Their image management has become more efficient, and their diagnostic capabilities have improved. Overall, the team has delivered a high-quality solution that meets the client’s requirements.

Country

USA

Type

Web System

Duration

Ongoing

Team Size

2-5 Specialists

Industry

Healthcare

Tech stack

C++ Python MQTT AWS IoT Core PostgreSQL Scrum

Read full review →

5.0

Verified by Clutch

“The application perfectly meets the large-scale demands of the project, with the team creating an effective solution that works well and provides the required level of control. They were communicative, responsive, and proactive throughout the project, demonstrating their experience at all times.”

Daniel Beasley

CTO at Healthi

Feedback summary

The application perfectly meets the large-scale demands of the project, with the team creating an effective solution that works well and provides the required level of control. They were communicative, responsive, and proactive throughout the project, demonstrating their experience at all times.

Country

USA

Type

Web Platform

Duration

12 months

Team Size

10 Specialists

Industry

Healthcare

Tech stack

Java Spring Boot PostgreSQL AWS Docker

Read full review →

Explore our client success stories

Dental Health

Country Israel

Subindustry HealthTech

Type Web Platform

Our client, a service provider in the dental healthcare space, has benefited from the upgrade of a dependable, modular, and adaptable platform to assist orthodontists. The platform swiftly processes images by integrating AI and digital transformation into dental care practices, generating analytical reports within seconds. It facilitates the markup of reference points on X-ray images, assisting in planning medical intervention procedures.

Safety Healthcare

Country USA

Subindustry HealthTech

Type Web and Mobile App System

Our client, Safety Healthcare, specialises in advanced patient identification and safety solutions. The company wanted to provide digital transformation for tracking and managing medical equipment without delays in patient care and inefficient resource utilisation. Our team developed an intuitive application using RFID tags and barcodes for real-time equipment tracking. The solution boosted revenue by 56% and reduced checkout time by 74%, significantly improving operational efficiency and patient care.

+ NDA cases

Since Computools strictly adheres to NDAs with its clients, additional case studies are not publicly available.
Please fill out the contact form, and our experts will respond to your inquiries.

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FAQ / Frequently Asked Questions

What types of medical devices require custom software?

Custom software is essential for devices like infusion pumps, ECG machines, wearable monitors, surgical robots, imaging systems, and in-vitro diagnostic equipment. Software enables functionality, real-time data processing, connectivity, and regulatory reporting.

How is safety and risk managed in medical device software development?

Software for medical devices follows rigorous risk management protocols, including hazard analysis, failure mode assessments (FMEA), cybersecurity evaluations, and validation under quality management systems to ensure patient safety and system reliability.

What regulatory standards must medical device software comply with?

Medical device software must meet strict standards such as FDA 21 CFR Part 820, IEC 62304, ISO 13485, and, in some cases, MDR (EU) or HIPAA (US). Compliance ensures safety, traceability, and approval for use in clinical settings.

Can Computools support both hardware integration and cloud connectivity?

Yes. We specialize in integrating device firmware with cloud platforms, EHR systems, and mobile apps. Solutions support real-time data syncing, OTA updates, remote diagnostics, and interoperability for IoMT ecosystems.

What if a startup only has hardware or a clinical idea but no tech team?

That’s not a barrier. Computools provides full technical leadership, covering architecture, UI/UX design, development, DevOps, and QA. Acting as a technology partner, our team collaborates closely with founders, clinicians, and advisors to turn medical concepts into compliant, scalable digital solutions.

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WHAT HAPPENS NEXT?

01.

We deeply analyse your request.

02.

We create project roadmap, accelerating your time-to-value.

03.

We co-scope features, minimizing project risk upfront.

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Computools is a global software development company and IT consulting partner