Quality Innovation, Fast & Affordable
Quality Innovation, Fast & Affordable
Royceville is a Canada-based innovation company specializing in in vitro diagnostics (IVD) and advanced Point of Care Testing (POCT) solutions. Headquartered in Ottawa, our team of seasoned R&D scientists and engineers brings decades of experience in developing high-performance diagnostic technologies that move efficiently from concept to commercialization.
Our mission is simple: enable rapid product development while maintaining uncompromising standards of quality, regulatory compliance, and cost-efficiency. We follow rigorous design control procedures and strategically integrate global engineering and manufacturing resources, including established partnerships in China, to optimize scalability and production readiness.
Royceville is led by Dr. Roy Zhao and Mr. Antti Virtanen, supported by a multidisciplinary engineering team with deep expertise in IVD systems.
Dr. Roy Zhao earned his PhD in Biomedical Engineering from the Karolinska Institute. With over 17 years in the IVD industry, he has held executive and scientific leadership roles, including Principal Scientist and VP of Technology at two diagnostic companies. He has successfully directed cross-functional teams to bring multiple POCT platforms from early-stage concept through regulatory approval and commercial launch. These include a PT/INR Analyzer and an Automatic Microfluidic qPCR Analyzer, with more than 10,000 PT/INR systems currently supporting cardiovascular patients worldwide.
Mr. Antti Virtanen holds an MSc in Organic Chemistry from the University of Turku.
With over 18 years of experience at a globally recognized POCT company, he has led the development of advanced diagnostic assays, including quantitative hs-TnI for rapid myocardial infarction diagnosis and TBI biomarker testing for brain injury assessment. His expertise spans microfluidics, cross-functional leadership, and collaboration across manufacturing, regulatory, and quality systems to deliver market-ready diagnostic innovations.
Our engineering team, comprised of over 20 electronic, software and mechanical engineers, has delivered medical device solutions for more than a dozen customers worldwide during the past decade. Together, we combine deep scientific knowledge with practical development expertise to bring innovative diagnostic products from concept to market efficiently and reliably.
Our team with strong expertise in IVD reagent, electronics, software and mechanical engineering has delivered medical device solutions for more than a dozen customers worldwide. Together, we combine deep scientific knowledge with practical development expertise to bring innovative diagnostic products to market efficiently and reliably.
Our engineering team combines scientific depth with hands-on execution across:
We have delivered medical device solutions to more than a dozen global clients, supporting them through feasibility, verification, validation, and commercialization phases.
At Royceville, we do more than develop diagnostic products, we build scalable, reliable, and clinically impactful solutions that strengthen healthcare delivery worldwide.
Our handheld PT/INR analyzer is a compact Point of Care Testing (POCT) device designed for professional and personal use. As part of our in vitro diagnostics (IVD) expertise, it delivers accurate INR results in under one minute. Users simply insert a disposable test strip and apply a drop of fingertip blood to obtain reliable coagulation data.
The INR result supports cardiovascular patients in monitoring Warfarin therapy under medical supervision.
Our team managed complete product development, including requirement definition, reagent and diagnostic assay development, test strip design, and analyzer engineering (electronics, software, and mechanics). We also led verification, validation, clinical trials, and achieved regulatory approvals including NMPA registration and CE Marking.
This point-of-care molecular diagnostic platform consists of a compact analyzer and a disposable test cartridge. It integrates microfluidic technology with fluorescent PCR to make the entire diagnostic process fully automated, from DNA extraction and precise metering to multiplex PCR amplification, melting, and data analysis.
The cartridge can be preloaded with specific reagents for detecting various target genes, enabling fast and accurate qualitative and quantitative PCR, melting-curve analysis, and genotype identification.
Our team led the research and development (R&D) process, defining detailed product requirements and performance specifications. We designed both the analyzer and the microfluidic diagnostic cartridge, including electronic circuits, embedded software, and mechanical components. This innovation reflects our commitment to advancing portable diagnostic devices and reliable POC testing equipment for efficient molecular analysis.
The Fecal Sample Processor is an automated system designed for precise and safe fecal sample preparation. Built with a focus on Quality Innovation, it integrates Sample Transfer, Weighing, Uncapping/Capping, Liquid Adding, Homogenizing, and Barcode Scanning modules into one streamlined platform.
For each sample, the system automatically weighs the specimen, calculates the required preservation solution, dispenses it accurately, recaps the tube, and transfers it for homogenization. This fully replaces manual handling, improving efficiency, consistency, and laboratory biosafety.
The Processor supports modern POC testing equipment workflows and aligns with advancements in portable diagnostic devices.
Our team defined the product requirements and specifications and developed the electronic circuits, software systems, and mechanical components.
This fully automated DNA extractor utilizes the magnetic bead adsorption method to isolate high-quality nucleic acids from biological samples. A magnetic rod inserted into a disposable plastic sleeve attracts magnetic beads to the sleeve surface, enabling their transfer between reaction wells containing specific reagents. When the rod is withdrawn, the beads are released, allowing precise collection, washing, and elution through sequential processing steps.
The system ensures high purity, reproducibility, and contamination control, making it suitable for in vitro diagnostics (IVD) and advanced POC testing equipment applications.
Our team led the complete product development cycle, including defining technical requirements and specifications, and designing the electronic circuits, embedded software, and mechanical structures.
This advanced pathological lab workstation integrates multiple diagnostic and staining technologies into a single, unified platform. It supports immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), HE drop staining, nucleic acid molecular hybridization (HPV), and liquid-based cytology staining. By consolidating these critical workflows, the system improves laboratory efficiency, reduces manual handling, and enhances result consistency across diverse pathological applications.
As the first solution of its kind in the industry, it is designed for use in bioengineering, cellular research, tissue analysis, and clinical pathology laboratories. The workstation aligns with modern in vitro diagnostics (IVD) requirements and supports evolving diagnostic assay development needs.
Our team led the complete development process, including defining product requirements and technical specifications, as well as designing the electronic circuits, control software, and mechanical systems to ensure precision, reliability, and scalability.
This semi-automatic 8-channel liquid dispenser functions as eight synchronized pipettes, enabling simultaneous transfer of liquids from one set of eight wells to another. Specifically designed for 96-well plate applications, it delivers high precision, repeatability, and operational efficiency in routine laboratory workflows.
The system simplifies repetitive liquid handling tasks, minimizes operator fatigue, and significantly reduces pipetting errors, improving overall data reliability. Its cost-effective design makes it suitable for research laboratories, clinical testing environments, and POC testing equipment applications. The device also supports workflows commonly used in diagnostic assay development.
Our team defined the complete product requirements and technical specifications, and engineered the electronic circuits, embedded software, and mechanical structure to ensure accuracy, durability, and ease of use.
We provide end-to-end product development services for in vitro diagnostics (IVD) companies across North America, supporting both new product creation and design optimization. Our expertise covers reagent formulation development, system and module design, prototyping, testing, and manufacturing process improvement.
Following strict design control procedures, we ensure full compliance with CE, FDA, and Health Canada requirements. Our structured Research and Development (R&D) process emphasizes efficiency, traceability, and regulatory readiness.
We collaborate closely with clients to define detailed product requirements, focusing on usability and ergonomics, and translate them into comprehensive system specifications. Prototypes are designed, built, and tested with manufacturability in mind, supported by design reviews, verification, validation, and risk analysis.
We deliver fully functional prototypes and complete technical documentation, ready for regulatory submission and scalable production, including solutions for Point of Care Testing (POCT) applications.
We adhere rigorously to design control procedures in full compliance with CE, FDA and Health Canada requirements. Our structured product development process ensures efficiency, reliability, and regulatory readiness:
Our deliverables include fully functional prototypes and complete technical documentation, prepared for submission to regulatory authorities, e.g., CE Marking, FDA and Health Canada.