Medical Device Software Development Services

Medical device software development is the process of designing, building, testing, and maintaining software that either runs a medical device or works on its own for diagnosis, monitoring, or treatment. We build both types, from software embedded inside devices to standalone apps, following the quality and regulatory standards US healthcare products require.

Software as a Medical Device (SaMD) is software intended for one or more medical purposes that performs those purposes without being part of a hardware device. Examples include apps that analyze medical images or calculate drug doses. The FDA regulates SaMD by risk, classifying it as Class I, II, or III.

Look for a US-based team with real experience in FDA Class I device software, IEC 62304 lifecycle documentation, and design controls. We build medical device apps this way, pairing senior engineers with regulatory-ready processes so your submission holds up. Always ask a partner to show products they have actually shipped and cleared.

An app becomes a regulated medical device when it is intended for a medical purpose, such as diagnosing a condition, guiding treatment, or analyzing patient data. General wellness and fitness apps usually fall outside FDA oversight. If your app influences clinical decisions, plan for FDA requirements early.

Common frameworks include FDA pathways such as 510(k) and PMA, 21 CFR Part 820 and Part 11, IEC 62304, ISO 13485, ISO 14971 for risk management, and EU MDR for CE marking. We also build with HIPAA guidelines in mind, with hands-on experience across FDA Class I to III and IEC 62304 software safety classes.

AI powers features like medical image analysis, patient risk prediction, clinical decision support, and workflow automation inside device software. We embed AI natively, using tools such as large language models and AWS Bedrock, while keeping models explainable and traceable enough to meet FDA expectations.

The cost depends on a few key factors: device risk class, feature scope, system integrations, and regulatory requirements. A simple Class I tool takes far less to build than a submission-ready Class III system. We map this precisely during discovery, so you get a clear estimate before any development begins.

Timelines depend on complexity and FDA class. A working MVP can take a few months, while a fully compliant, submission-ready Class II or III product often takes 6 to 18 months or more. We use agile, iterative delivery, so you get a usable version early while building toward full compliance in parallel.

We support HL7 and FHIR integration with EHR and EMR systems, device connectivity over Bluetooth, Wi-Fi, and 5G, and cloud platforms including AWS, Azure, and Google Cloud. Our teams work across the full stack, from embedded device interfaces to cloud data pipelines, so your product fits into existing healthcare systems.

We build security into the development lifecycle from day one, not as an afterthought. That includes encryption of data at rest and in transit, role-based access control, regular penetration testing, and a secure development process. We handle protected health information carefully and adhere strictly to HIPAA regulations.