Medical Device Software
Developers
IT Craft builds software for medical devices and provides dedicated developers
with deep expertise in the healthcare industry.
Medical Device Software Solutions
We Develop
We develop medical device software for diagnostic equipment and connected devices that require secure
device connectivity, real-time health data synchronization and reliable clinical performance.
Software as a Medical Device (SaMD)
Our developers create medical devices for diagnostic, monitoring, and therapeutic functions while supporting FDA, MDR, and IEC 62304 requirements.
Comprehensive Medical
Device Software
Development Services
Built for Compliance
Consulting, embedded development, Software as a Medical Device (SaMD), mobile applications, IoMT connectivity and lifecycle support for building compliant medical device software for MedTech companies.
Consulting
Our specialists assess technical, regulatory, and business requirements to define the optimal architecture, compliance strategy, and development roadmap.
Custom Software Development
We provide custom medical device software development for embedded systems and connected healthcare solutions tailored to your product.
Mobile App Development
IT Craft developers create native and cross-platform medical device app development solutions for remote monitoring, device management, patient engagement, and secure health data access.
Integration Services
Our engineers integrate medical devices with EHR/EMR systems, hospital platforms, cloud services, wearables, third-party healthcare applications, HL7, FHIR, and DICOM.
Software Modernization
We upgrade legacy medical device software to improve performance, security, interoperability, compliance, and cloud connectivity while minimizing operational risks.
Testing & Validation
Our team performs functional, performance, usability, interoperability, and verification testing to support software quality, safety, and regulatory compliance.
Maintenance & Support
IT Crft firm provides continuous monitoring, updates, regulatory support, security improvements, performance optimization, and software lifecycle support.
Why Healthcare Organizations Choose
IT Craft for Medical Device Software
Development
IT Craft acts as a trusted partner in medical device development, combining 20+ years of software engineering expertise and hands-on experience to build FDA-ready and IEC 62304-compliant software with fewer delivery and compliance risks.
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Experience with Diverse Medical Devices
Our agency uses extensive experience with patient monitoring systems, diagnostic platforms, wearable health technologies, and Software as a Medical Device (SaMD) to choose the right delivery approach for your product. -
Regulatory Compliance
Our experts apply knowledge of standards, FDA guidance, industry standards, HL7, FHIR, and DICOM to streamline documentation and prepare software for smoother regulatory submissions. -
End-to-End Development
IT Craft provides complete medical device software development services, from requirements analysis and design through development, testing, deployment, and maintenance, so you can keep one team responsible for the full product lifecycle. -
Cybersecurity & Data Protection
Our specialists implement secure development practices and data protection measures for connected medical devices and healthcare applications to reduce security risks before and after release. -
Strong Quality Assurance & Validation
We perform verification, validation activities, automated and manual testing, performance testing, usability testing, and documentation to support compliance requirements and safer product launch. -
Long-Term Support
Our firm provides ongoing maintenance, software updates, performance optimization, and lifecycle management after deployment to keep your medical device software stable, secure, and ready for future changes.
Our Proven Medical Device Software
Development Process
Technology Stack
Frequently Asked
Questions
IT Craft develops Software as a Medical Device (SaMD) and custom software for in-hospital, in-home, and on-body medical devices. Our solutions support real-time monitoring, secure data collection, device management, and seamless integration with healthcare systems and connected medical devices, including:
- In-hospital: Smart carts, blood collection devices, medical imaging solutions.
- In-home: Smart inhalers, voice assistants, baby care devices, smart thermometers.
- On-body: Smartwatches, fitness trackers, blood pressure and heart rate monitors, glucometers, insulin pumps.
The cost of medical device software development depends on product complexity, regulatory requirements, integrations, validation scope, and the level of documentation needed for release.
Most projects:
- start at $40,000 for an MVP
- may exceed $500,000+ for enterprise-grade, FDA-compliant medical device solutions
The timeline depends on the type of product, required integrations, validation depth, and regulatory documentation.
Typical development timelines include:
- 4–6 months for an MVP
- 12–18+ months for complex medical device software requiring extensive validation, integrations, and regulatory documentation
Yes. IT Craft develops medical device software in accordance with FDA guidance, IEC 62304, and other applicable standards. Our team integrates compliance and quality assurance across the development lifecycle to support safer releases, clearer documentation, and smoother regulatory preparation.
Yes. We design and develop secure, scalable Software as a Medical Device (SaMD) solutions for:
- diagnostics
- patient monitoring
- clinical decision support
- digital therapeutics
Each solution is built with regulatory and interoperability requirements in mind.
Yes. Our team integrates medical devices with EHR/EMR systems and broader healthcare infrastructure.
We use healthcare standards and secure connectivity tools, including:
- HL7
- FHIR
- DICOM
- secure APIs
These integrations enable seamless data exchange between devices, clinical systems, and healthcare platforms.
We apply security-by-design practices to protect medical device data and patient information throughout development and after release.
This includes:
- encryption
- secure authentication
- role-based access control
- audit trails
- vulnerability testing
- compliance with HIPAA, GDPR, and other applicable regulations
Yes. IT Craft modernizes legacy medical device software while preserving regulatory continuity and reducing operational risks.
Modernization may include:
- reengineering
- cloud migration
- UI/UX improvements
- performance optimization
- technology upgrades
- support for regulatory compliance
Yes. IT Craft provides post-launch support to keep medical device software secure, stable, and ready for future updates.
Our services include:
- ongoing maintenance
- software updates
- security enhancements
- performance optimization
- regulatory compliance support
- long-term technical assistance
