Software as a medical device

Your SaMD Technology Partner

We build Software as a Medical Device

that is ready for regulators, clinicians, and real world use

CitrusBits partners with healthcare and digital health teams to design, engineer, and scale SaMD products that pass regulatory review, integrate into clinical workflows, and deliver measurable patient outcomes.

SaMD adoption is accelerating across healthcare, but building and scaling these products remains complex. Regulatory readiness, clinical alignment, and real world usability continue to slow down even well funded teams. Execution has become the deciding factor between approval, adoption, and long term success.

The global SaMD market is projected to reach 86 billion dollars by 2027, reflecting the growing role of software in medical care.

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The global SaMD market is projected to reach 86 billion dollars by 2027, reflecting the growing role of software in medical care.

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The global SaMD market is projected to reach 86 billion dollars by 2027, reflecting the growing role of software in medical care.

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The global SaMD market is projected to reach 86 billion dollars by 2027, reflecting the growing role of software in medical care.

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Demand is rising, but compliance
adoption, and execution remain
the real readblocks

FDA expectations misunderstood early

SaMD documentation overwhelms teams

Compliance added after development

Clinical workflows poorly supported

Scaling breaks regulated systems

When a SaMD product isn’t architected for regulation from day one, teams face expensive rework, delayed approvals, and lost credibility with regulators and clinicians. Strong SaMD development starts with the right foundation, before the first line of code is written. CitrusBits helps SaMD teams move forward with clarity, confidence, and speed. The right decisions at the start determine whether your product reaches patients, or stalls indefinitely.

What We Offer

Engineering SaMD for Patients, Providers, and Regulators

We support SaMD products across the full lifecycle, from early concept through regulatory clearance and long term scale. Our approach aligns product design, engineering execution, integration, and compliance so teams can move forward without rework or surprises.

Product Design

Engineering

Integration

Compliance

AI and Data

Future Growth

01

MedTech and Device Manufacturers

Connected hardware companies that require companion applications, cloud platforms, and digital systems built to meet regulatory and real world usage requirements.

Digital Health and Virtual Care Platforms

Startups and enterprises developing regulated software for diagnostics, monitoring, telehealth, and patient engagement.

02

03

Life Sciences and Pharmaceutical Organizations

Teams building digital therapeutics, adherence solutions, and clinical trial platforms that extend therapies beyond the clinic.

Healthcare Providers and Systems

Hospitals and clinics adopting SaMD products for diagnostics, treatment planning, workflow optimization, and chronic care delivery.

04

05

Vision and Emerging Tech Innovators

Organizations in ophthalmology, audiology, AR, VR, and wearables developing next generation diagnostic, assistive, and therapeutic technologies.

Connected & IoT Medical Device Companies

Organizations managing regulated software across connected devices, sensors, and data pipelines in secure, scalable environments.

06

Who We Build SaMD With

SaMD and Regulated Healthcare Work

A selection of regulated software and healthcare platforms built in collaboration with leading life sciences and health technology organizations.

Roche

Johnson & Johnson

RadiusXR

Novartis

Roche

Johnson & Johnson

RadiusXR

Novartis

Trusted by Healthcare and
Technology Leaders

Some of the brands we have worked with

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.