Software as a medical device
We build Software as a medical device solutions that move Healthcare forward
CitrusBits designs, engineers, and delivers Software as a Medical Device that passes regulatory review, integrates into clinical workflows, and improves patient outcomes. From concept to reality, our solutions are ready for hospitals, clinics, and patients. Recognized with industry-leading awards, our work reflects a commitment to healthcare innovation that drives both clinical and operational impact.
$86B
The SaMD market is projected to reach 86 billion dollars by 2027, reflecting the growing role of software in medical care.
65%
of digital health leaders report delays in bringing SaMD products to market due to regulatory and integration challenges.
600+
More than 600 SaMD products have already received FDA clearance, yet many fail to scale because of poor user adoption and clinical misalignment.
70%
of companies that work with experienced external partners reduce their time-to-market compared to those relying only on internal teams.
These numbers tell the story clearly. Demand is rising, but compliance, adoption, and execution remain the roadblocks. This is where CitrusBits steps in.
Who We Partner With
We collaborate with innovators across the healthcare ecosystem, tailoring SaMD solutions to their specific challenges and goals.
Connected hardware companies that need companion apps, cloud systems, or digital platforms to meet regulatory and user requirements.
Startups and enterprises building regulated applications for diagnostics, monitoring, telehealth, and patient engagement.
Teams creating digital therapeutics, adherence tools, and clinical trial platforms that extend therapies into patients’ daily lives.
Hospitals and clinics adopting SaMD products for diagnostics, treatment planning, workflow optimization, and chronic care.
What We Offer
Engineering SaMD for Patients, Providers, and Regulators
Product Design
We create SaMD products that balance patient usability with clinical precision. Our design process makes complex medical technology simple to use while still meeting the needs of regulators and care providers.
- Human-centered design sessions with patients, caregivers, and clinicians
- Prototypes tested in simulated clinical workflows before development
- Interfaces designed for accessibility, including vision- or mobility-impaired users
- Patient engagement features that encourage adherence and long-term use
- Clinical dashboards that help providers make faster, data-informed decisions
Engineering
Our engineering teams build SaMD platforms that are robust, reliable, and prepared for FDA or CE review. We combine software craftsmanship with a clear understanding of regulatory pathways.
- Full-stack development covering mobile, web, and cloud environments
- Integration of device firmware and wearable data streams
- Real-time monitoring and alert systems built with redundancy
- Scalable architecture designed to support both pilot trials and commercial rolloutssAutomated testing frameworks to reduce defects and support regulatory submissions
Integration
SaMD products often fail when they cannot connect to the broader healthcare ecosystem. We make integration seamless, ensuring providers can adopt new solutions without disruption.
- HL7 and FHIR-compliant integrations with major EHR platforms (Epic, Cerner, Allscripts)
- API development for interoperability between devices, apps, and hospital systems
- Secure data synchronization across multiple care sites and devices
- Audit trails and reporting that meet clinical record-keeping requirements
- Cloud-to-on-premise connectivity for hybrid healthcare environments
Compliance
Compliance is where many SaMD projects stall. We embed it into the entire lifecycle so your product is clearance-ready from day one.
- HIPAA compliance for data storage, transfer, and privacy
- FDA Class II and III pathways mapped into the development plan
- CE mark readiness for European marketsISO 13485 quality management for medical devices
- ISO 27001 information security practices applied to every project
- Documentation prepared for audits, clinical submissions, and regulatory filings
AI and Data
Artificial intelligence is redefining SaMD, but it requires rigorous design and validation. We help you harness AI responsibly while ensuring clinical and regulatory trust.
- Development of explainable AI models for diagnostics and monitoring
- Clinical trial–ready datasets and training pipelinesBias testing and validation to ensure fairness and reliability
- Predictive analytics for patient outcomes and disease progression
- AI-driven triage systems that improve speed and accuracy of care
Future Growth
A successful SaMD product must evolve with changing clinical practices, new devices, and emerging regulations. We future-proof your solution for scalability and expansion.
- Modular architecture allowing new features without full rebuilds
- Cloud infrastructure that scales as user adoption grows
- Data pipelines supporting longitudinal studies and real-world evidence generation
- Continuous updates aligned with new FDA or CE regulations
- Ongoing clinical feedback loops to adapt features for doctors and patients
- Product lifecycle management for long-term sustainability
Our Work
Check out a few of the game-changing digital innovations we have built for partnering visionaries.
Roche
Roche partnered with CitrusBits to develop a digital therapeutic platform supporting individuals with autism spectrum disorder. The project focused on creating a patient-friendly solution grounded in behavioral therapy protocols while meeting strict regulatory standards. Working alongside Harman, CitrusBits contributed design and engineering expertise to ensure the platform was clinically aligned, HIPAA-compliant, and prepared for FDA and CE review.
Johnson & Johnson
Johnson & Johnson’s Actelion subsidiary partnered with CitrusBits to build a mobile research platform that gave global teams secure, personalized access to critical medical literature on rare diseases. The iOS solution integrated RightFind’s API, introduced advanced collaboration features, and was developed with SaMD-level rigor around compliance, security, and usability, enabling researchers to accelerate discovery and improve collaboration across the organization.
RadiusXR
RadiusXR partnered with CitrusBits to design and build a vision testing and practice management platform integrated with its proprietary XR headset. The solution combined gold-standard diagnostics with an immersive patient media library, delivering a HIPAA-compliant, EHR-integrated system that reduced patient visit times, doubled practice capacity, and earned recognition as a CES Innovation Awards Honoree.
Novartis
Novartis, through its acquisition of Kedalion Therapeutics, partnered with CitrusBits to create a companion mobile app for Kedalion’s innovative eyedrop delivery device. The app introduced dosage tracking, real-time reminders, and caregiver support, built with SaMD-level compliance and reliability to improve adherence and strengthen Novartis’ digital therapeutics portfolio in ophthalmology.
Some of the Brands we have worked with...
What Our Trusted Partners And Clients Say
The team is great. They were extraordinarily attentive and really kept us honest. We actually took a trip to CitrusBits’ office and found them to be very hospitable, friendly, and knowledgeable. I’m impressed with their patience and their speed. CitrusBits was willing to go the extra mile for us. They worked with us when we had questions and put a lot of effort into the project. They were just great people to work with.
Julian Velazquez
Silicon Valley Innovation Center Leader,
DuPont
“The project was a great success. We have shared the app internally and received highly positive feedback. We have also used the app with a potential customer, who was impressed with the software product, potentially generating a sale. CitrusBits is impressive in many respects, but their results stand out the most. We have a great app that allows us to demonstrate our product and produce revenue.”
Douglas Schumacker
Account Manager
Samsung
“My experience working with CitrusBits has been excellent. Outstanding software teams are resilient, and our developers at CitrusBits have certainly proven to be that. Our CitrusBits friends have become as close to team members as possible, and I am grateful for the care and excellence they have provided.”
Tom Perski
VP of Outreach,
RadiusXR
What our trusted partners and clients say...
DuPont
Samsung
RadiusXR
Technology Partners
Trusted by Industry Leaders
We collaborate with the world’s leading technology innovators to build resilient, scalable, and compliant healthcare solutions. Our partnerships ensure CitrusBits clients benefit from the most advanced platforms, cloud services, and device integrations available today.
Book Your Free Roadmap Consultation
Explore how our technology solutions can transform your business.
Our Offices
U.S. Headquarters
5994 W. Las Positas Blvd.
Suite 101,
Pleasanton, CA 94588
USA
APAC Main Office
Plot 375-B, Street 16,
Potohar Road, I-9/3,
Islamabad, Pakistan
