Question 1

How long does it take to get FDA 510(k) clearance for a medical device app?

Accepted Answer

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.

Question 2

What is the cost of developing a companion app for a Class II medical device?

Accepted Answer

Development costs for a Class II medical device companion app typically range from $5,000 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.

Question 3

Do you provide support for FDA submissions, or just software development?

Accepted Answer

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.

Question 4

Can you develop medical device apps that work offline for patient safety?

Accepted Answer

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.

Question 5

Can you integrate our medical device app with hospital EHR systems?

Accepted Answer

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 to mobile app, and medical device data to 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.

Question 6

Do you have experience with AI and ML in regulated medical devices?

Accepted Answer

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.

Question 7

How do you ensure HIPAA compliance for medical device apps?

Accepted Answer

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, 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.

Question 8

What post-market support do you provide after app launch?

Accepted Answer

Kesem Solutions provides comprehensive post-market support including: Post-Market Surveillance System with automated monitoring for adverse events, app crashes, and security vulnerabilities. Regulatory Compliance with Medical Device Reporting to FDA, incident reporting to TGA, and PMCF for CE Mark. Software Maintenance including bug fixes, OS updates, security patches, and performance optimization. Change Control with proper regulatory documentation for all software changes per IEC 62304. Customer Support with end-user helpdesk, clinician training, and technical troubleshooting. Continuous Improvement with new feature development based on user feedback and real-world evidence.

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