Medical Device App Development

Medical device app development requires specialized expertise in regulatory compliance, hardware integration, and clinical validation. Kesem Solutions delivers FDA 510(k), TGA, and CE Mark-compliant mobile applications for medical device manufacturers across Australia and the United States.

Our medical device app development services include companion apps for implantable and external devices, patient controller applications with Bluetooth Low Energy (BLE) integration, physician configuration tools, and Software as a Medical Device (SaMD) solutions that meet IEC 62304 and ISO 13485 quality standards.

Medical Device App Development Services

Companion Apps for Medical Devices

We develop patient-facing companion apps that seamlessly integrate with implantable and external medical devices. Our companion app development includes real-time device monitoring, therapy adjustment interfaces, battery status tracking, and secure device-to-cloud data synchronization. Every companion app undergoes rigorous validation testing to ensure reliable BLE connectivity and offline-first functionality for uninterrupted patient access.

Patient Controller Applications

Our patient controller applications empower patients to manage their therapy settings directly from their smartphones. These apps feature intuitive interfaces for therapy adjustment, usage history tracking, travel mode controls, and symptom logging. Each patient controller app is designed with accessibility in mind, meeting WCAG 2.1 AA standards and supporting both iOS and Android platforms.

Physician Configuration Tools

Clinician-facing apps require specialized workflows and enhanced security. We build physician configuration tools that enable healthcare providers to program devices, review patient data, adjust therapy parameters remotely, and export clinical reports. These tools integrate with hospital IT systems via HL7 FHIR APIs and support secure authentication with HIPAA-compliant audit logging.

Software as a Medical Device (SaMD)

Our SaMD development follows FDA guidance for software lifecycle management and risk-based validation. We develop clinical decision support systems, diagnostic algorithms, remote patient monitoring platforms, and digital therapeutics that qualify as Class I, II, or III medical devices. Every SaMD project includes comprehensive documentation for regulatory submissions including 510(k) premarket notifications and PMA applications.

Regulatory Compliance for Medical Device Apps

Medical device app development demands strict adherence to global regulatory frameworks:

  • FDA Compliance (United States): 510(k) premarket notification, PMA applications, QSR (Quality System Regulation), and post-market surveillance
  • TGA Compliance (Australia): Therapeutic Goods (Medical Devices) Regulations, conformity assessment, and Australian Register of Therapeutic Goods (ARTG) listing
  • CE Mark (European Union): Medical Device Regulation (MDR), technical documentation, and Notified Body review
  • IEC 62304: Medical device software lifecycle processes including software development planning, risk management, and verification/validation
  • ISO 13485: Quality management systems for medical device design, development, and production
  • ISO 14971: Application of risk management to medical devices with comprehensive hazard analysis and mitigation strategies

Our team has successfully navigated FDA 510(k) clearances, TGA Class IIa/IIb certifications, and CE Mark applications for companion apps integrated with implantable neuromodulation devices, urological monitoring systems, and clinical data collection platforms.

Technical Capabilities in Medical Device Software

Bluetooth Low Energy (BLE) Integration

We specialize in BLE protocol implementation for medical device communication. Our apps handle complex pairing workflows, encrypted data transmission, connection stability monitoring, and firmware updates over the air (FOTA). We've integrated with custom BLE GATT profiles for proprietary medical device protocols and industry-standard profiles like Bluetooth SIG Health Device Profile (HDP).

Device-to-Cloud Architecture

Our medical device apps feature robust device-to-cloud architectures with secure REST APIs, MQTT for real-time telemetry, and AWS IoT Core or Azure IoT Hub for scalable device management. All data transmission uses TLS 1.3 encryption with certificate pinning, and we implement token-based authentication with automatic credential rotation.

Offline-First Mobile Design

Patient safety requires apps to function without internet connectivity. We build offline-first architectures with local SQLite databases, background sync queues, and conflict resolution algorithms. Critical device controls remain accessible offline, with automatic data synchronization when connectivity is restored.

Cross-Platform Development

We develop native iOS apps in Swift and Android apps in Kotlin for maximum performance and platform integration. For select projects, we use React Native or Flutter to accelerate time-to-market while maintaining native module access for BLE communication and device sensors. Every app supports the latest OS versions and undergoes compatibility testing on 20+ device models.

Medical Device App Development Process

  1. Regulatory Strategy & Risk Assessment: We begin every medical device app development project with a comprehensive regulatory strategy session. Our team identifies the device classification (Class I/II/III), applicable regulations (FDA, TGA, CE Mark), predicate devices for 510(k) submissions, and required clinical evidence. This phase includes ISO 14971 hazard analysis and software risk classification per IEC 62304.
  2. Requirements Specification & Design Controls: We document software requirements specifications (SRS) that map to intended use, user needs, and risk mitigations. Our design controls process includes architectural design specifications, interface specifications for device communication protocols, and traceability matrices linking requirements to verification tests.
  3. Agile Development with Design History File (DHF): Development follows Agile sprints while maintaining complete DHF documentation. Each sprint includes peer code reviews, static analysis with SonarQube, and unit test coverage targets of 85%+. We use JIRA for requirements traceability and GitLab for version control with branch protection and audit trails.
  4. Verification & Validation Testing: Our QA process includes verification testing (does the software meet specifications?) and validation testing (does it meet user needs?). We conduct functional testing, usability testing with representative users, cybersecurity penetration testing, and interoperability testing with device hardware across environmental conditions.
  5. Clinical Evaluation & Usability Engineering: For higher-risk devices, we conduct formal usability studies per IEC 62366 (Application of usability engineering to medical devices). This includes formative evaluations during design, summative validation with real users, and human factors risk analysis to identify use errors and implement mitigations.
  6. Regulatory Submission Support: We prepare technical documentation for regulatory submissions including Software of Unknown Provenance (SOUP) analysis, cybersecurity documentation per FDA premarket guidance, software bill of materials (SBOM), and validation reports. Our team supports QA/RA departments throughout the submission and review process.

Medical Device App Development Case Studies

Neuromodulation Patient Controller

Challenge: A medical device manufacturer needed a smartphone patient controller app for their sacral neuromodulation system. The app required FDA PMA clearance, bidirectional BLE communication, therapy adjustment controls, and integration with an existing wireless transmitter.

Solution: We developed a native iOS patient controller app with intuitive therapy adjustment sliders, battery monitoring, usage history visualization, and travel mode activation. The app implemented a custom BLE GATT profile with encrypted command transmission and implemented offline-first architecture for reliable access.

Outcome: FDA PMA clearance obtained. App deployed to 10,000+ patients with 4.8-star App Store rating. Zero critical device connectivity failures reported in post-market surveillance.

Urological Health Monitoring Platform

Challenge: A digital health startup needed a bladder monitoring app combining sensor hardware integration with patient-reported outcomes. The solution required FDA 510(k) clearance, TGA Class IIa certification, and clinical validation.

Solution: We built a cross-platform monitoring app with BLE sensor connectivity, bladder diary workflows, symptom tracking, AI-powered insights, and clinician dashboard. The platform included HL7 FHIR integration for EHR data exchange and implemented ISO 13485 quality management.

Outcome: FDA 510(k) clearance and TGA listing achieved. Clinical study with 500+ participants demonstrated improved patient outcomes. Platform scaled to support 50,000+ users.

Clinical Data Collection App for Research

Challenge: An academic medical institution required a mobile app for multi-site clinical trial data collection. The app needed secure patient enrollment, electronic consent (eConsent), scheduled assessments, and real-time data synchronization with a central REDCap database.

Solution: We developed a HIPAA-compliant data collection app with offline survey completion, encrypted local storage, automated data validation, and REDCap API integration. The solution included role-based access control for research coordinators and real-time enrollment dashboards.

Outcome: Deployed across 12 clinical sites. 2,000+ participants enrolled. Zero data loss incidents. 98% data completeness rate.

Why Choose Kesem Solutions for Medical Device App Development

  • Regulatory Expertise: Our team has successfully obtained FDA 510(k) clearances, TGA certifications, and CE Mark approvals for multiple medical device apps. We understand Design Control requirements, DHF documentation, and regulatory submission processes.
  • Hardware Integration Experience: We've integrated apps with 15+ different medical device hardware platforms including implantable neuromodulation systems, wearable biosensors, diagnostic equipment, and external therapeutic devices. Our BLE expertise ensures reliable device connectivity.
  • Quality-First Development: Every project follows ISO 13485 quality management with comprehensive design controls, risk management per ISO 14971, and software lifecycle processes per IEC 62304. We maintain complete traceability from requirements through verification.
  • Security & Privacy: All medical device apps implement HIPAA-compliant data handling, encryption at rest and in transit, secure authentication, and regular security audits. We follow NIST Cybersecurity Framework and FDA cybersecurity guidance.
  • Clinical Understanding: Our team includes developers with clinical backgrounds who understand patient workflows, clinician needs, and healthcare system integration challenges. We design apps that improve clinical outcomes, not just meet technical specifications.
  • Post-Market Support: We provide ongoing maintenance, post-market surveillance support, software updates for OS compatibility, and regulatory change management. Our support includes monitoring adverse events and implementing corrective actions when needed.

Related Medical Device Services

Looking for additional medical device development services? We also offer:

Start Your Medical Device App Development Project

Ready to develop a compliant, reliable medical device app? Our team brings regulatory expertise, technical excellence, and clinical understanding to every project. Whether you're building a companion app for an implantable device, developing SaMD, or need support with FDA/TGA submissions, we're here to help.

Typical Project: $5,000 - $200,000 AUD | 1-8 months | FDA/TGA compliant

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