Administrative Assistant, HR Associate, Technical Writer, Librarian
Our expertise includes both extensive design of Class II and III medical devices and a broad development of consumer products. We specialize in advanced electrical engineering and embedded software development. It is our commitment to provide advanced thinking and technologies to our clients to help them bring their ideas to market. Our capabilities include:• Class I, II and III medical devices• Design and development• Analog and digital hardware design• Software design and development• Digital signal processing, algorithm implementation and verification• Human factors assessment• Risk assessment• Agency Certifications• Medical device combination products, multiparameter monitoring systems, opto-electrical products• Compliance with medical device regulations including 21CFR part 820, and ISO 13485, ISO 62304, 61010-1, 61010-1-2, 60601-1 and 60601-1-2• Phase-gate New Product Development process management, Verification & Validation• Biphasic Defibrillator Design and Implementation, Including comparative waveform trials• Blood Glucose Meter• Implantable Arrhythmia Monitor / Telemetry System, Custom Analog ASIC, RF• Wireless sensors and systems for medical devices• Device Cyber-security• Coexistence testing