About Us

Rapid, Reliable Diagnostics for Better Patient Care.

Founded in 1996 in Taipei, JDBIOTECH has over two decades of experience in the In Vitro Diagnostics (IVD) market. After seven years of solid growth, we expanded our focus to include the development of innovative products and the exploration of new market opportunities. In 2005, we achieved key milestones, including GMP certification and ISO 13485 approval for our operations in Jinan, China. Our commitment to quality and continuous improvement drives us to deliver cutting-edge IVD Point-of-Care solutions that enhance patient care globally.

Our Lab Certification

Quality Policy

As manufacturer, we provide a comprehensive range of rapid test products and services to minimize the impact of infectious diseases on patients. This quality policy focuses on the essence of quality, which is the degree to which a product’s or service’s characteristics meet actual requirements. The management undertakes to meet the objectives:

Commitment to comply with the legal requirements that are applicable, in addition to complying with the customer’s requirements and the requirements of the Quality Management System implemented, based on ISO13485:2016 standards and EU IVDR.

Commitment to promote the maintenance and continuous improvement of the Quality Management Systems implemented, using all resources it deemed necessary to strengthen these bases and the achieve of our objectives.

Commitment to effectively control all our activities, with special emphasis on the quality and safety of our products, their maintenance and continuous evolution, as well as personalized and prompt customer service and satisfaction.

Commitment to promoting an understanding and dissemination of our Quality Policy with in our organization, through continuous training and communication with out employees.

Quality objectives

JDBIOTECH is committed to the design, development, manufacture, and distribution of innovative medical devices that meet the highest quality standards required by our customers and regulatory bodies.

Our objective is to consistently deliver exceptional products and services, supported by a robust Quality Management System (QMS), which is subject to continuous improvement to ensure its ongoing effectiveness.

To support this commitment, JDBIOTECH has implemented a QMS that aligns with the following standards and regulations:

Our Commitment to Safe,
Effective, and Quality-Assured Medical Devices

In line with our commitment to product safety and efficacy, JDBIOTECH performs thorough risk analysis for all medical devices, identifying inherent risks and applying rigorous mitigation measures to ensure compliance with safety and performance requirements.

Furthermore, the storage and distribution of our products are managed under strict environmental controls, ensuring product security, hygiene, and quality are maintained throughout the process.

This policy applies to all employees and represents our commitment to:Rapid, Reliable Diagnostics for Better Patient Care