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Medical Device

WEARABLE ECG PATCH

To support Company’s expansion into wearable health monitoring, Garrett Technologies, Inc. was engaged to develop a Bluetooth-enabled ECG patch that integrates seamlessly with mobile and cloud infrastructure. The goal: deliver a 14-day, single-use, FDA-compliant cardiac monitoring patch with robust data capture and wireless transmission. This complex multi-phase project required end-to-end product development, system integration, and compliance engineering aligned with ISO 13485 and IEC 62304.

Garrett’s multidisciplinary approach enabled company to accelerate wearable product innovation, navigate complex technical requirements, and prepare the ECG patch for clinical validation and regulatory submission.

WE DELIVERED

  • Project planning, cost modeling, BOM estimation

  • Product architecture and system requirements

  • Design History File (DHF) development and documentation

  • Disposable, wearable system material selection and development

  • Mechanical, electrical, and software engineering

  • Bluetooth Low Energy (BLE) API and embedded firmware development

  • Mobile/cloud integration coordination and interface specification

  • Alpha and Beta prototyping, build management

  • System integration and bench testing

  • Agency testing support (FDA 510(k) class II, with potential CE mark)

  • Verification, validation, and performance testing

  • Support for contract manufacturer (CM) onboarding

  • Algorithm development (QRS detection, heart rate, beat-to-beat analysis)

  • Packaging interface and mechanical form factor design

  • Risk analysis, requirement traceability

  • Regulatory readiness (IEC 60601, 62304, ISO 10993, UL/FCC planning)

  • Production transfer support (First Article Inspection, CM coordination)

  • Post-launch engineering support and updates