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Clinical & Preclinical
We've accumulated thousands of hours of clinical and preclinical experience supporting products in cardiac catheter and cardiac electrophysiology labs throughout the US, Europe, South America, and Asia. Products include implantable pacemakers, defibrillators, diagnostic and ablation catheters, and neurostimulators.
We employ deep project management experience to identify and mitigate potential risks in complex projects. We meet or exceed industry and PMI (certified) standards for project management practices and apply the latest tools and methodologies to execute projects.
Nocturnal's optical experience encompasses laser systems, fiber and electro-optics, and biophotonics. The team boasts particular expertise with spectroscopy for optical characterization of living tissue via both diffuse reflectance and fluorescence.
As a recipient of Small Business Technology Transfer grants (STTR), Nocturnal has experience working together with small companies and universities to obtain and manage grant funding from federal, state, and local governments.
Nocturnal has designed, developed, and implemented extensive analog and digital circuitry to meet the demands of medical products. Nocturnal's deep experience in electromagnetic compatibility (EMC) and electrical safety testing enables us to consider the demands of international regulatory standards at the onset of the design process.
Nocturnal's mechanical engineering capabilities include electronics packaging, structural finite element analysis, and thermal analysis, as well as the more artistic aspects of the product like industrial design, human factors, and graphic design.
Quality & Regulatory
Nocturnal is an ISO 13485:2016 certified and 21 CFR Part 820 - maintaining design history files, performing risk analysis, and planning and executing verification and validation activities. We support clinical investigations in US and OUS settings with IDE and other clinical trial submissions and assist in obtaining domestic and international approvals by developing regulatory strategies and authoring CE, 510(k), and PMA submissions. We are also a Departement of Defense Registered Contractor.
Software and Embedded Systems
We've implemented countless embedded systems for medical devices, working with platforms like ARM Cortex, MSP430, PIC, DSPs, and embedded Linux. We also develop applications in Windows & iOS to support, control, and interface with medical devices.
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