Medical
Devices

• Design of precision analog front-ends (AFE) for bio signal acquisition (EEG, ECG, EMG, etc.)
• Ultra-low-power designs with BLE for connected medical devices
• Expertise in battery-operated wearables and implantable with sub-µA sleep modes
• Embedded firmware development on RTOS, Embedded Linux, or Bare-metal
• Signal acquisition, real-time filtering, preprocessing & diagnostics

• IEC 62304-compliant embedded software
• Feature-rich B2C mobile apps for connected medical devices
• Multi-platform support: iOS, Android, Flutter, React Native
• BLE integration, real-time data sync, therapy tracking, and user engagement features
• HIPAA/GDPR-compliant cloud infrastructure for data storage, access, and analytics
• Secure OTA firmware updates and device management frameworks

• BLE 5.x, Wi-Fi, NB-IoT, Zigbee, Thread, LoRa
• Interoperability with EMR systems using HL7/FHIR APIs
• Secure onboarding, provisioning, remote monitoring, and device control
• IoT platform integration with alerting, data visualization, and predictive analytics

Gadgeon integrates end-to-end cybersecurity from architecture to post-deployment, addressing the evolving threats in connected healthcare systems:

• Secure Boot & Firmware Validation to prevent unauthorized code execution
• Device Identity Management and certificate-based authentication (PKI, X.509)
• Encrypted BLE Communication with session key generation, pairing modes (LE Secure Connections), and anti-spoofing
• Application Layer Security: TLS/SSL for cloud and mobile communication
• Mobile App Hardening: Secure key storage, anti-tamper mechanisms, obfuscation
• Threat Modelling & Penetration Testing aligned with FDA and OWASP IoT guidelines
• Compliance with FDA Premarket Cybersecurity Guidance, MDR, and ISO 81001-5-1
• Regular Vulnerability Scans, firmware signing, secure OTA update process
• Cloud Security: Identity and access control, audit logging, anomaly detection, data encryption (at rest and in transit)
• Incident response planning and post-market surveillance security processes

• Consulting services to help achieve and maintain compliance with ISO 13485 and IEC 62304.
• Software validation as per FDA's guidance including design control, verification, and validation activities.
• Risk management and validation aligned with ISO 14971 standards.
• Development of automated test suites to streamline the validation process for compliance with industry regulations.
• Traceability & documentation for regulatory approval
• Cybersecurity testing for FDA & Industry Standards.
• Support for submission processes to FDA, CE marking, and other certification authorities.

• Companion apps for smart wearables (ECG, SpO₂, Motion sensors)
• BLE-connected injectors and inhalers with compliance tracking
• Apps for remote therapy guidance, chronic condition management, and digital diagnostics
• Personalized dashboards for patients and clinicians
• Long-term engagement strategies with reminders, gamification, and secure messaging

• Ensure a smooth transition from design to production and beyond.
• DFM (Design for Manufacturing) and DFA (Design for Assembly) support to optimize product designs for efficient and cost-effective production.
• Supply Chain & Procurement Management with inventory management, forecasting, and logistics coordination to maintain a steady flow of materials for production.
• Logistics & Fulfilment with management of shipping, warehousing, and distribution channels to ensure timely delivery of products to global markets.
• Ensuring production processes and products comply with relevant international standards and regulations (such as CE, FCC, UL, ISO, and RoHS).
• Implementation of rigorous quality measures, including test tools, test jigs, and evaluation kits.
• Support for submission processes to FDA, CE marking, and other certification authorities.

• Black-box, white-box, and grey-box test methodologies
• Unit, integration, system, and regression test cases
• Test automation using tools like Squish, Robot Framework, PyTest, Jenkins, LabVIEW, and more
• Custom test harnesses for firmware and device interfaces

• Functional testing of real-time embedded software
• RTOS task-level behaviour validation
• Edge-case and stress testing for BLE, Wi-Fi, sensor inputs, and communication stacks
• Compliance checks for software safety classes A/B/C under IEC 62304

• Simulation of real-world inputs and faults to verify firmware response
• Integration of HIL platforms for automated firmware validation
• Sensor and actuator emulation for end-to-end device behaviour testing

• Penetration testing and static/dynamic code analysis
• Validation of encryption protocols, secure OTA, access control, and data protection
• Security risk analysis per FDA Premarket Cybersecurity Guidance and ISO/IEC 81001-5-1

• Conducting formative and summative usability testing
• Ensuring device and app interfaces are intuitive and safe under real-world conditions
• Alignment with IEC 62366-1 and FDA human factors guidance

• Functional testing of B2C mobile apps and clinician dashboards
• Cross-platform testing (iOS, Android, Web) for UI consistency, performance, and edge-case handling
• Cloud API testing, load simulation, and data validation across HIPAA-compliant systems

Gadgeon provides all V&V artifacts required for regulatory submissions and audits, including:

• Verification and validation plans
• Test protocols and traceability metrics
• Execution reports with pass/fail status and defect logs
• Risk-based testing evidence per ISO 14971
• Audit support for FDA, CE, and ISO submissions

• Strong grasp of medical software safety classes and lifecycle processes
• Ability to scale across manual and automated test efforts
• V&V integrated with DevOps/CI-CD workflows for faster releases
• Deep experience across connected devices, mobile apps, and cloud platforms
• Hands-on expertise in real-time, low-power, and BLE-based systems