NOVO Engineering

Engineering services spanning Class I, II, and III device design, drug delivery systems, and diagnostic instruments. The development process integrates design control documentation to support clinical trials and regulatory submissions.

• Class I, II, and III Device Engineering
• Drug Delivery Systems Engineering
• Diagnostic and Monitoring Instrumentation
• Single-Use and Durable Consumables
• Design Control and Regulatory Documentation
• Clinical Trial Unit Manufacturing

Iterative design and rapid prototyping of bioreactors, cartridge fluidics, and automated lab systems. Systems are engineered to integrate proprietary assays with robust mechanical and electronic hardware.

• Bioreactor and Automated Cell Culture Systems
• Reagent Cartridge and Microfluidic Systems
• Assay Instrumentation for qPCR and ELISA
• Lab Automation and Robotics Integration
• BSL-2 Lab Space Validation and Testing

System-level engineering for advanced industrial and commercial printing systems, integrating precise hardware, firmware, and fluid dynamics.

• Inkjet Printhead and Fluid System Engineering
• 3D Printer Hardware and Firmware Engineering

Full product design and engineering services that transform new concepts into commercialized consumer and industrial products.

• Consumer and Industrial Product Engineering
• Concept Generation to Pilot Manufacturing

Design and integration of automated assembly and test systems to streamline manufacturing processes, improve throughput, and secure product quality.

• Automated Test Equipment and Software
• Manufacturing Process Automation Systems
• Robotics and Motion Control Integration

Comprehensive transfer of design data to manufacturing partners, supported by onsite prototyping and clinical build capabilities.

• Pilot Manufacturing and Prototyping Operations
• Manufacturing Transfer Documentation
• Onsite CNC Machining and Model Shop Services

Multi-disciplinary engineering covering physical components, electrical layouts, and printed circuit board design.

• Mechanical Component Engineering
• Electronics and PCB Layout Engineering
• Rapid Prototyping and Onsite 3D Printing

Development of reliable embedded firmware and client application software to control physical devices and execute system test scripts.

• Embedded Firmware Engineering
• Device Application and Companion Software
• Automated Test Execution Software

An integrated engineering discipline ensuring that hardware, software, and human factors work harmoniously to meet design requirements.

• Product Requirements Definition
• Design for Manufacturability Analysis
• Verification and Validation Testing Protocols
• User Experience and Interface Engineering

Quality management procedures structured for compliance with international standards and national drug and device administrations.

• ISO 13485 Quality Management Systems
• FDA Design Control Workflows
• Regulatory Submission Documentation Preparation