Quality Certifications and Awards
Accumulated Achievements from Systems to Results
Quality Foundation | System Capabilities Supporting Diagnostic Stability
In the in vitro diagnostic industry, quality management is the core foundation that ensures product stability and application reliability. Centered on allergen testing and extended into in vitro diagnostic technologies and related health applications, Excelsior Bio-System Incorporation has long established a quality management system that complies with international standards.
From raw material development, product manufacturing, to quality control processes, Excelsior Bio-System Incorporation operates under strict regulatory standards. Through external certifications, award recognitions, and participation in national-level projects, the company has continuously built a stable foundation of technology and industrial capability.
International Quality Systems and Manufacturing Standards
Excelsior Bio-System Incorporation has implemented a comprehensive quality management system to ensure consistency, traceability, and application reliability throughout product development and manufacturing processes. Through standardized management and process control, R&D outcomes are stably transformed into practical applications, supporting consistent performance of in vitro diagnostic products across different application fields.
ISO 13485 Medical Device Quality Management System
Quality management system (QMS) compliant with medical device manufacturing standards
Cleanroom manufacturing environment established in accordance with ISO 14644-1 standards
Medical device manufacturing and related regulatory licenses
These systems and standards are not only requirements within the production process, but also reflect Excelsior Bio-System Incorporation’s commitment to product stability, diagnostic quality, and long-term application reliability.
Manufacturing Environment | From R&D Outcomes to Stable Application
Stable diagnostic products are derived from a controllable manufacturing environment and quality processes. Excelsior Bio-System Incorporation has established compliant manufacturing and testing environments, and through its quality management system, controls raw materials, processes, and finished product testing, enabling product development to transition smoothly from R&D to mass production and real-world application.
For Excelsior Bio-System Incorporation, quality management is not limited to final inspection; it is an integrated process that spans R&D, manufacturing, quality control, and application. Through a stable manufacturing environment and quality assurance mechanisms, the company continuously supports the development of allergen testing, in vitro diagnostic reagents, and various health application scenarios.
International Quality Systems and Manufacturing Standards
Excelsior Bio-System Incorporation has accumulated multiple recognitions from government and industry institutions in technology development, product applications, and corporate operations. These awards are not only records of individual achievements, but also reflect the company’s long-term commitment to innovation, industrial application, and in vitro diagnostic technologies.
Business and Management Recognition
Excelsior Bio-System Incorporation has received multiple recognitions in business management and industrial development, including:
Taipei City Industrial Development Subsidy Program – Investment Benchmark Outstanding Enterprise
Ministry of Economic Affairs Incubation Acceleration Excellence Enterprise / Incubation Pioneer
Agricultural Technology Enterprise Innovation Award / Innovative R&D Category
These recognitions demonstrate the company’s continuous progress in biotechnology industry operations, R&D investment, and industrialization development.
Technological Achievements and Product Application Recognition
In in vitro diagnostics, allergen testing, and related technological applications, Excelsior Bio-System Incorporation has also received multiple awards recognizing its technological and product achievements, including:
11th National Innovation Award
16th National Innovation Award / Innovation Advancement Award
Pharmaceutical Technology Research and Development Award / Medical Device Category – Bronze Award
These awards reflect the company’s ongoing commitment to diagnostic technology development, product commercialization, and application value, further strengthening professional trust in its allergen testing and in vitro diagnostic fields.
Pandemic Applications and Participation in National Projects
During periods of rapidly changing public health needs, Excelsior Bio-System Incorporation leveraged its existing diagnostic platforms and R&D experience to engage in the development and supply of related testing technologies, becoming part of the domestic in vitro diagnostic ecosystem.
During the pandemic, Excelsior Bio-System Incorporation participated in the development and supply of pandemic-related diagnostic products and accumulated experience in the development of antibody, antigen, and neutralizing antibody testing products. These achievements were also recognized by the Pharmaceutical Technology Research and Development Award, reflecting the company’s technical capability and industrial value in pandemic applications and in vitro diagnostic product development.
International Certifications and Key Achievements
In addition to its quality systems and domestic awards, Excelsior Bio-System Incorporation has continuously accumulated international certifications and key technological achievements, expanding the application of its diagnostic technologies into broader global markets.
Among these achievements, the Excelsior Bio-System Incorporation “African Swine Fever Antibody Rapid Diagnostic Reagent” received international registration certification from the World Organisation for Animal Health (WOAH), representing a significant milestone in livestock disease diagnostics. This certification not only demonstrates the company’s R&D capabilities in animal disease testing technologies, but also reflects that its products and technologies meet the requirements for entry into international validation systems.
Learn About Livestock Disease DiagnosticsPatent Technologies and R&D Achievements
Quality and technical capability are not the result of a single achievement, but rather the accumulation of long-term R&D investment and process optimization. Excelsior Bio-System Incorporation continues to invest in allergen testing, in vitro diagnostics, and related technology platform development, and advances the depth of diagnostic products and application capabilities through R&D programs, patents, and technological achievements.
Excelsior Bio-System Incorporation has recently obtained two utility model patents related to rapid test reagent manufacturing devices, continuously strengthening its diagnostic manufacturing processes, product stability, and integrated R&D–production–sales capabilities. These patent achievements also reflect that the company not only possesses diagnostic technology development capabilities, but also continuously optimizes production processes and real-world application workflows.
Utility Model Patent | Rapid Test Reagent Lamination Device (M680769)
Utility Model Patent | Rapid Test Reagent Lamination Device (M680769)
R&D Programs and Continuous Technological Investment
Excelsior Bio-System Incorporation has long been dedicated to the development of allergen testing and in vitro diagnostic technologies, continuously advancing the optimization of technology platforms and the expansion of application areas. Through R&D programs and the accumulation of technological achievements, the company has been able to extend its capabilities into diverse diagnostic needs and application fields.
These R&D investments, together with the aforementioned quality systems, certifications, awards, and patent achievements, mutually reinforce one another, enabling Excelsior Bio-System Incorporation to continuously build a stable foundation from technology to real-world applications.
