Medical device, SaMD and AI health app development
Selected work: Medical Device App Development Projects
Medical Device App Development Specialists
Kesem Solutions develops regulatory-compliant mobile medical device applications for medical device manufacturers, digital health startups, and healthcare technology companies worldwide. Based in Melbourne, Australia, we deliver FDA 510(k) and PMA-cleared, TGA-approved, and CE Mark certified mobile applications that meet IEC 62304, ISO 13485, and HIPAA compliance requirements.
Why Medical Device Manufacturers Choose Kesem Solutions
Rapid prototyping and agile development within regulated frameworks—get your companion app cleared in 6-12 months, with some projects achieving FDA 510(k) clearance in as little as 8 months.
Mobile & Web Development
Speed to Market Rapid prototyping and agile medical device app development within regulated frameworks—get your companion app cleared in 6-12 months, with some projects achieving FDA 510(k) clearance in as little as 8 months.
Cloud & Integration
Our medical device app development services Leveraging AWS and cloud technologies for seamless app integration. Cost-Effective 40-60% lower cost than US-based medical device software agencies while maintaining full regulatory compliance. Fixed-price quotes after discovery phase for budget certainty.
UI/UX Design
Creating intuitive, user-friendly designs that enhance user experience. With End-to-End Support From clinical requirements analysis to post-market surveillance systems. medical device app development and complete regulatory documentation (DHF, SRS, SDS, V&V) and submission support.
AI App Development
Creating smart, AI-powered apps to transform user experiences. With Proven Regulatory Success Successfully cleared apps through FDA PMA (highest level), FDA 510(k), TGA, and CE Mark processes for Class II and Class III medical devices.
Medical Device App Development Services
We develop regulatory-compliant mobile applications for medical devices across multiple categories, specializing in companion apps for implantable devices, clinical data collection platforms, and AI-powered diagnostic tools.
Read about our AI development services.
companion apps for medical devices
Successfully, developed , deployed, registered and currently CI/CD a Patient controller applications and physician configuration apps that work seamlessly with implantable and external medical devices.
Key Capabilities:
• Bluetooth Low Energy (BLE) Medical Device Integration
• Real-Time Device Monitoring (battery, therapy parameters, diagnostics)
• Remote Device Programming within physician-defined safety ranges
• Clinical Data Synchronization (HIPAA-compliant cloud sync)
• Offline-First Architecture for patient safety
Device Categories:
• Neuromodulation Systems (sacral nerve stimulation, spinal cord stimulation)
• Urological & Pelvic Health Devices
• Cardiac Monitoring Devices
• Diabetes Management (CGM, insulin pumps)
• Diagnostic & Rehabilitation Devices
Regulatory Compliance:
✓ IEC 62304 Software Lifecycle
✓ ISO 14971 Risk Management
✓ FDA Cybersecurity Guidance
✓ Design History File (DHF) Documentation
clinical mobile applications
Standalone digital health applications for clinical workflows, patient engagement, and therapeutic interventions.
Application Types:
• Clinical Data Collection Apps (eCRF, patient-reported outcomes)
• remote patient monitoring (RPM) for chronic disease management
• digital therapeutics (DTx) - prescription digital health interventions
• Clinical Decision Support Systems (CDSS) with AI
• Patient Engagement Apps (medication adherence, secure messaging)
• Bladder & Bowel Diaries for urological/gastroenterological tracking
Healthcare System Integrations:
• HL7 FHIR Integration (bidirectional EHR/EMR data exchange)
• Epic, Cerner, Allscripts Integration
• DICOM Medical Imaging
• Laboratory Information Systems (LIS)
• Pharmacy Systems (e-prescribing)
Platforms:
✓ Native iOS (Swift/SwiftUI)
✓ Native Android (Kotlin)
✓ React Native (cross-platform)
✓ Flutter
AI & machine learning in healthcare
AI-powered clinical applications for Software as a Medical Device (SaMD) with machine learning components.
AI Healthcare Capabilities:
• Clinical Natural Language Processing (NLP) or clinical NLP
• Retrieval-Augmented Generation (RAG) for Clinical Knowledge; might also refered as RAG systems
• Predictive Analytics (risk stratification, disease progression)
• Computer Vision for Medical Imaging (dermatology, radiology, pathology)
• Personalized Treatment Recommendations
• Symptom Checkers & Triage Systems
AI Technologies:
• Large Language Models: OpenAI GPT-4,5,5.2 , Anthropic Claude, Google Vertex AI, Meta Llama
• Vector Databases: FAISS, Pinecone, Weaviate
• Medical NLP: BioBERT, ClinicalBERT,
• Cloud AI: AWS HealthLake, Google Healthcare API, Azure Health Data
Regulatory Compliance:
✓ FDA AI/ML-Based SaMD Guidance
✓ Good Machine Learning Practice (GMLP)
✓ Clinical Validation Studies
✓ Explainable AI (XAI) for regulatory acceptance
See our RAG system case study.
healthcare data security Compliance
Every medical device and digital health application meets the highest standards for data security, patient privacy, and regulatory compliance.
Compliance Standards:
• HIPAA Compliance (US) - BAA, encryption, audit logging
• Australian Privacy Act & OAIC Guidelines
• GDPR (European Union)
• ISO 27001 Information Security
• ISO 13485 Quality Management
Security Architecture:
• End-to-End Encryption (AES-256 at rest, TLS 1.3 in transit)
• Zero-Knowledge Architecture (client-side encryption)
• Multi-Factor Authentication (biometric, FIDO2)
• Role-Based Access Control (RBAC)
• Comprehensive Audit Logging
• Secure Cloud Infrastructure (AWS HIPAA, Azure Healthcare)
Development Standards:
✓ IEC 62304 Medical Device Software Lifecycle
✓ ISO 14971 Risk Management
✓ IEC 62366 Usability Engineering
Our Medical Device Software Development Process
Rigorous, regulatory-compliant software development lifecycle based on IEC 62304, ISO 13485, and ISO 14971. Our agile-within- our medical device app development services, regulatory framework enables rapid iteration while maintaining full traceability and compliance documentation.
Learn more about our team.
Phase 1: Discovery & Regulatory Strategy (2-3 weeks)
- • Clinical requirements analysis and workflow mapping
- • Device classification determination (Class I/II/III)
- • Regulatory pathway selection (510(k), PMA, TGA, CE Mark)List Item
- • Risk assessment (ISO 14971, FMEA)List Item
- • Predicate device identification
Phase 2: Design & Architecture (3-4 weeks)
- • Software Requirements Specification (SRS)
- • Software Design Specification (SDS)
- • UI/UX design with clinical usability validation
- • Traceability matrix (requirements → design → tests)
- • Security architecture (encryption, authentication)
Phase 3: Agile Development (8-12 weeks)
- • 2-week sprints with stakeholder demos
- • IEC 62304 software safety classification
- • Comprehensive unit and integration testing
- • Design History File (DHF) documentation
- • Change control and anomaly tracking
Phase 4: Verification & Validation (4-6 weeks)
- • Software verification (building it right)
- • Software validation (building the right thing)
- • Usability testing (IEC 62366)
- • Clinical validation studies
- • Cybersecurity penetration testing
Phase 5: Regulatory Submission (2-4 weeks)
- • Complete DHF compilation
- • 510(k)/PMA/TGA submission package preparation
- • Submission review and consultation
- • Response to regulatory questions
Phase 6: Launch & Post-Market Surveillance (Ongoing)
- • App Store launches (iOS & Android)
- • Adverse event monitoring (FDA MDR, TGA reporting)
- • Performance metrics and crash monitoring
- • Regular software updates with change control
Frequently Asked Questions:
Medical Device App Development
How long does it take to get FDA 510(k) clearance for a medical device app?
Typical timeline for FDA 510(k) clearance is 6-12 months from project kickoff to FDA clearance letter. This includes 3-4 months for development, 2-3 months for verification/validation, 1 month for submission preparation, and 3-4 months for FDA review.
Kesem Solutions has achieved 510(k) clearances in as little as 8 months by running development and V&V activities in parallel and preparing documentation throughout the process rather than at the end. Our experience with regulatory submissions reduces back-and-forth with FDA, accelerating approval.
What's the cost of developing a companion app for a Class II medical device?
Development costs for a Class II medical device companion app typically range from $40,000 to $200,000 AUD, depending on complexity.
This includes requirements analysis, design, development (iOS and/or Android), regulatory documentation (DHF, SRS, SDS, V&V protocols and reports), testing, and submission support.
Kesem Solutions offers 40-60% cost savings compared to US-based medical device agencies while maintaining full regulatory compliance. We provide fixed-price quotes after the discovery phase, so you have budget certainty.
Simple patient controllers start around $20K, while complex diagnostic apps with AI can reach $150-200K.
Do you provide support for FDA submissions, or just software development?
Kesem Solutions provides end-to-end support from initial concept through FDA clearance. We prepare all software-related sections of your 510(k) submission including software description, Level of Concern determination, software V&V documentation, cybersecurity documentation, and labeling.
We work with your regulatory consultant (or recommend one) to compile the complete 510(k) package. We also support responses to FDA questions or deficiencies related to software. Our team has successfully navigated FDA PMA, 510(k), TGA, and CE Mark submissions for multiple Class II and Class III medical device apps.
Can you develop medical device apps that work offline for patient safety?
Yes, offline-first architecture is a specialty of Kesem Solutions.
We design medical device apps where all critical functions (therapy control, device monitoring, safety features) work without internet connectivity. This is essential for patient safety—a patient should never lose control of their implanted device due to poor cellular signal.
We use local databases (SQLite, Realm) for data storage, local BLE communication for device control, and queue-based synchronization for non-critical cloud features. Our neuromodulation and urological device apps all operate 100% offline, with cloud sync as an optional enhancement.
Can you integrate our medical device app with hospital EHR systems?
Yes, we specialize in healthcare interoperability using HL7 FHIR (Fast Healthcare Interoperability Resources) standard. We can integrate your medical device app with Epic, Cerner, Allscripts, and other major EHR platforms.
This enables seamless data flow: patient data from EHR → mobile app, and medical device data → EHR for clinical documentation. We implement SMART on FHIR for secure authentication, patient matching, and data exchange. Our integrations are HIPAA-compliant with proper Business Associate Agreements (BAA) and audit logging. We also support older HL7 v2 interfaces and custom API integrations if needed.
Do you have experience with AI/ML in regulated medical devices?
Yes, Kesem Solutions develops AI-powered medical device software following FDA guidance on Software as a Medical Device (SaMD) with Machine Learning. We have experience with clinical decision support algorithms, diagnostic AI, and predictive analytics in regulated environments.
This includes defining algorithm performance specifications, conducting clinical validation studies, implementing algorithm change protocols, and documenting Good Machine Learning Practice (GMLP).
We work with explainable AI (XAI) architectures that satisfy regulatory requirements for transparency and clinical interpretability. Our AI medical device projects include urinary flow pattern recognition (iUFlow) and symptom-based triage systems.
How do you ensure HIPAA compliance for medical device apps?
HIPAA compliance is built into every aspect of our medical device apps. Technical safeguards include: AES-256 encryption for data at rest, TLS 1.3 for data in transit, encrypted local databases on mobile devices, secure key management, multi-factor authentication, and session timeouts.
Administrative safeguards include: Business Associate Agreements (BAA) with all vendors (cloud providers, analytics), employee HIPAA training, access control policies, and incident response procedures. We implement comprehensive audit logging for all access to protected health information (PHI), breach notification systems, and regular security assessments. Our apps are architected to minimize PHI collection (data minimization principle).
What post-market support do you provide after app launch?
Kesem Solutions provides comprehensive post-market support including:
(1) Post-Market Surveillance System: automated monitoring for adverse events, app crashes, security vulnerabilities, and user feedback;
(2) Regulatory Compliance: Medical Device Reporting (MDR) to FDA, incident reporting to TGA, PMCF for CE Mark, annual product reviews;
(3) Software Maintenance: bug fixes, OS updates (new iOS/Android versions), security patches, performance optimization;
(4) Change Control: proper regulatory documentation for all software changes per IEC 62304;
(5) Customer Support: end-user helpdesk, clinician training, technical troubleshooting;
(6) Continuous Improvement: new feature development based on user feedback and real-world evidence.
We offer flexible support contracts (monthly retainers or incident-based) to fit your budget and stage of growth.
Ready to Develop Your Medical Device App?
Get expert guidance on regulatory strategy, technical feasibility, timeline, and budget for your medical device mobile application.
Schedule Your Free Consultation
30-minute call to discuss:
✓ Device classification and regulatory pathway (FDA/TGA/CE Mark)
✓ Technical architecture and BLE integration requirements
✓ Timeline and cost estimate for your project
✓ Risk assessment and mitigation strategies
✓ How we've helped similar device manufacturers succeed
Review our recent projects or schedule a consultation.👇