Hannah Son's Contact Details

Hannah Son's Company Details

MedISAO

Irvine, California, United States • 1 - 10 Employees
Medical Device

Promenade Software provides services and solutions for the rapid development of medical devices and other connected embedded systems. From drug delivery to complex in vitro diagnostic medical devices, our tools and expertise in firmware, device and mobile apps, and cloud integration get your product developed ultra-efficiently with exceptional quality.At Promenade we take pride in our work and are serious about the quality, and value we provide. We never off-shore, near-shore or any-shore our work; our work is done in Irvine, California. We are IEC 62304 compliant and our quality management is ISO 13485:2016 and ISO 9001:2015 certified. Custom Device Software Development for: • Class I, II, III devices - IVD Instruments - Drug Delivery Systems - Patient Monitoring - Imaging Systems - Surgical & Therapeutic Devices -SaMD (Software as Medical Device) • Wearables, Mobile Apps, Point-of-Care (POC), Floor-based Instruments • Cloud Platform and Integration • Premarket Cybersecurity - Regulatory Review - Threat Modeling - Risk Analysis - Implementation of Controls • Software Testing and V & V for Medical Devices • Regulatory Guidance and Documentation Planning