Connecting Devices. Enabling Decisions. Improving Outcomes.
Dogtown Media provides medical device software development as part of its broader mHealth app developer services.
What Medical Device App Development Delivers
Dogtown Media develops secure, compliant mobile medical device applications that interface directly with medical devices, giving providers real-time data, supporting patient adherence, and enabling informed decision-making.
Medical Device App Development Services
Our team brings proven expertise in HIPAA-compliant development, remote patient monitoring (RPM), and FDA regulatory pathways, including 510(k) submissions.
We help you design, develop, and deploy medical device applications that connect regulated hardware to secure mobile workflows, provider systems, and compliant data infrastructure.
From implantable devices and surgical tools to wearables and diagnostic sensors, today’s medical hardware demands intuitive, responsive software. We create medical device applications that synchronize across iOS, Android, and cloud-based EHR systems by using secure APIs, cloud services, and FHIR and DICOM standards. For connected sensors and wearables, we also support Bluetooth pairing, peripheral integrations, and medical wearable app development workflows so every stakeholder has access to timely, secure insights.
Medical Device App Development Process
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Discovery. We review your device environment, users, workflow constraints, and business goals at the start of the engagement.
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Intended Use Definition. We define intended use and indications for use so the medical device application scope, claims, and classification path are clear.
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Requirements Gathering. We document functional, technical, clinical, and interoperability requirements, including device behaviors, user permissions, and data handling needs.
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Risk Management. We identify safety, cybersecurity, privacy, and usability risks early so mitigation steps are built into the plan.
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Architecture. We design the application, integration layer, cloud environment, and traceability model around performance, security, and compliance requirements.
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Development. We build the medical device application, device interfaces, APIs, and supporting services with documentation aligned to IEC 62304 lifecycle controls.
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Verification and Validation. We execute unit, integration, system, and usability testing to confirm the software meets requirements and supports documented validation and verification evidence.
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Launch. We prepare release documentation, deployment controls, and operational handoffs for FDA planning, internal quality review, or commercial rollout.
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Post-Launch Support. We support change control, maintenance, monitoring, and revalidation as the application, device, and regulatory requirements evolve.
Compliance checkpoints are built into each phase so documentation readiness supports audits, submissions, and ongoing maintenance.
Medical Device App Types We Build
Remote Patient Monitoring (RPM)
Patients use these medical device applications to transmit vital signs from connected home devices to care teams, supporting chronic condition management, real-time alerts, and longitudinal trend tracking outside the clinic. This work aligns with the regulated data capture and review requirements for remote patient monitoring app development.
Clinical Trial Platforms
Study participants and coordinators use these medical device applications to sync wearable data, capture ePRO (electronic patient-reported outcomes), and route validated records to research systems. This supports clinical trial app development by improving protocol adherence, data accuracy, and trial readiness.
Diagnostics & Imaging
Clinicians use these medical device applications to receive imaging data, AI outputs, and visual display layers from connected systems, which support point-of-care decisions and structured diagnostic workflows.
Medication Management
Patients use these medical device applications to receive dosage guidance, interaction checks, and refill reminders, while medication data syncs with patient portals and care teams to reduce non-adherence and streamline refill workflows.
Chronic Disease Management
Patients and providers use these medical device applications to capture symptoms, biometric readings, and activity data over time, which supports long-term care for diabetes, asthma, arthritis, and related conditions through tracking, messaging, and wearable integration.
Surgical & Robotic Interfaces
Clinicians use these medical device applications to receive real-time surgical data and control inputs from robotic instrumentation, which enhances procedural precision and operating room efficiency.
Telemedicine Infrastructure
Patients and providers use these medical device applications to exchange visit data, asynchronous messages, and connected assessment results, which support virtual care delivery and device-assisted at-home evaluations.
How We Integrate Devices, Cloud Platforms, and EHR Systems
We connect medical devices to medical device applications through Bluetooth Low Energy, secure pairing flows, and peripheral device support for sensors, wearables, and in-clinic hardware. Data can move from the device to the application, through secure APIs to cloud services, and into provider dashboards or connected systems with validation rules at each step.
When clinical records or imaging data need to move across systems, we support interoperability patterns that use FHIR, HL7, and DICOM. We also account for offline handling, queued sync, consent logic, and error recovery so the medical device application can keep working when connectivity changes.
Medical Device Apps We’ve Built and Deployed
From concept to clinical use, Dogtown Media’s medical device applications are used by patients, physicians, and healthcare systems across the globe:
- SleepLife®: Developed with the National Sleep Foundation, this RPM application syncs with Fitbit to visualize sleep trends and push actionable data to physician dashboards.
- Bristol Myers Squibb: A clinical trial monitoring application that integrates with wearable sensors to alert care teams to dangerous vital sign fluctuations in real time.
- Marathon Health: A chronic care platform that helps employees track wellness scores, appointments, and biometric trends, integrated with Fitbit and Garmin devices.
These platforms support diagnosis, engagement, and real-time intervention.
Medical Device App Development Process
Dogtown Media develops medical device software with security and compliance at the core. We guide your project through the full lifecycle of regulatory readiness:
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HIPAA compliance. Privacy requirements shape data flows, consent capture, data retention, access controls, and regional handling rules throughout the build process.
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FDA 510(k) submissions and classification planning. This work affects intended use language, device claims, documentation strategy, and the evidence package needed for review.
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IEC 62304 software lifecycle controls. IEC 62304 defines how we document software development, change control, anomaly management, and release readiness for regulated environments.
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21 CFR Part 11 requirements. 21 CFR Part 11 affects electronic records, audit trails, e-signatures, and validation expectations for research and regulated workflows.
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SaMD strategy and connected software scope. Software as a Medical Device (SaMD) planning clarifies whether the application performs a medical function independently or supports a broader device system.
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RBAC and audit trails. RBAC (role-based access controls) determines which users can view, edit, approve, or export specific data based on role, and audit trails record those actions for review.
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ePRO workflow controls. ePRO (electronic patient-reported outcomes) requirements affect how patient questionnaires are captured, timestamped, reviewed, and stored in compliant research records.
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Encryption, secure APIs, consent logic, and data minimization. These controls protect data in transit and at rest while limiting collection to the information the workflow requires.
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ISO 13485-aligned controls, risk management, and validation and verification. These practices support traceability, documented reviews, test evidence, and release decisions across the lifecycle.
We’ve supported submissions and built compliant platforms for global pharma, clinical research organizations, and digital health startups alike. Our infrastructure meets ISO 13485-aligned design controls and supports rapid validation, verification, and risk mitigation.
Working With Dogtown Media
Our team combines product strategy, UX, requirements gathering, and medical device software engineering to move your medical device application from prototype to production with regulatory clarity built in.
- We bring a proven track record in mHealth and device integration.
- We plan for FDA, HIPAA, and international standards early in the delivery process.
- We build cross-platform applications with Bluetooth, IoT, and cloud connectivity in scope from the start.
- We support post-launch audits, maintenance, and ongoing compliance management.
Classification Expertise, Built In
How Intended Use Determines Classification
Intended use and indications for use determine whether your software qualifies as a medical device, a process we walk through in detail in our SaMD classification guide. Here, that means we start every engagement by pinning down intended use before any architecture decisions get made.
From companion apps for FDA-cleared devices to cloud-connected diagnostic platforms, we build the secure, validated software architecture regulated medical environments require.
Request a free consultation to discuss your medical device app project.
Medical Device App Development Process
What is the difference between SaMD and a companion app?
SaMD performs a medical function independently of any hardware device, while a companion app typically extends the setup, monitoring, or reporting functions of a specific device it's paired with. For the fuller breakdown, including how SaMD differs from SiMD, see our SaMD guide.
How do I know if Dogtown should build my product as SaMD versus a standard health app?
If your app is intended to diagnose, treat, monitor, or otherwise inform a clinical decision, it likely needs to be built and validated as SaMD, with the documentation, risk management, and evidence that come with that path. We make this call early, usually during discovery, by reviewing your intended use, target users, and clinical claims before any architecture work starts. Getting this right upfront avoids the more expensive problem of realizing mid-build that your app needs 510(k) clearance, design controls, or clinical validation it wasn't architected for. If you're unsure which path your product falls into, that's exactly what the first conversation is for.
Which regulations apply to medical device app development?
The answer depends on the product’s intended use, market, and data flows. Common requirements include HIPAA, GDPR, FDA device rules, IEC 62304, 21 CFR Part 11, and ISO 13485-aligned quality controls.
Can the app connect with wearables, Bluetooth devices, and EHR systems?
Yes. We support Bluetooth Low Energy, secure APIs, cloud sync, offline handling, and interoperability patterns that use FHIR, HL7, and DICOM for EHR and imaging workflows.
Do you support FDA 510(k) submissions and post-launch compliance?
We support classification planning, documentation readiness, and 510(k) preparation to help you build submission-ready software. While we don't file submissions directly, we prepare the technical documentation, validation evidence, and traceability records that regulatory teams need. We also support post-launch maintenance, change control, and ongoing compliance management.