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8 results for “IEC 62304”

• IEC 62304: Medical Device Software LifecycleStandardIEC 62304 is the international standard for the software development lifecycle of medical device software, scaled to safety class A, B, or C.
• Medical Wearable IoT: Remote Patient Monitoring and Continuous Health TrackingWhite PaperEngineering Connected Medical Wearables for the FDA 510(k) Pathway: Edge AI, Secure Connectivity and Clinical-Grade Biosensors
• Medical Device Compliance: FDA QMSR (21 CFR 820) & ISO 13485White PaperA Technical Summary of Regulatory Requirements for Connected Medical Devices
• Medical DevicesSolutionIEC 62304 / ISO 13485-aware medical device development.
• ECG, EEG and EMG Front-End Design GuideGuideAFE choice, noise, electrodes, isolation, IEC 60601 and IEC 62304, and 510(k), MDR and CDSCO pathways for medical biosignal wearables.
• Smart Urinometer: Automated ICU Urine Output Monitoring System with Real-Time AnalyticsCase studyDevelopment of a smart urinometer for ICU and post-surgical patients, with design documentation structured to IEC 62304 and ISO 13485 expectations, that automatically measures urine output, flow rate and colour. It is designed to replace manual hourly readings, with design targets of 40% less nursing time on urine monitoring and earlier detection of acute kidney injury (AKI).
• Automated Nitric Oxide Therapy System: Connected iNO Delivery for NICU PatientsCase studyDevelopment of an automated inhaled nitric oxide (iNO) therapy system for NICUs treating newborns with persistent pulmonary hypertension, with design documentation structured to IEC 62304 (Class C) and ISO 13485 expectations. It combines precise gas delivery, real-time NO/NO2 monitoring, cloud connectivity for remote oversight and layered safety interlocks, with a BOM-based estimate of a device cost about 60% below imported iNO delivery systems.
• AI-Powered Oxygen Therapy: Intelligent FiO2 Titration System for Critical CareCase studyDevelopment of a closed-loop oxygen therapy system, with design documentation structured to IEC 62304 and ISO 13485 expectations, that adjusts FiO2 automatically from real-time SpO2 monitoring and predictive algorithms. Design targets: 35% less oxygen consumption than manual titration and 98.5% time in the prescribed SpO2 range, with less hyperoxia and nursing workload.