OUR COMPANY

We are Certest

Cutting-edge IVD and nucleic acid solutions driven by proprietary biomaterials and a commitment to global health.

2002

foundation

330+

qualified employees

250,000

sqm of facilities

ISO 13485

certified QMS

89 IVDR

certified products

130+

countries worldwide

Founded in Zaragoza in 2002, Certest is an R&D-driven biotechnology company focused on proprietary biomaterials and the development and manufacturing of in vitro diagnostic solutions and nucleic acid-based technologies for the human clinical field.

We combine scientific expertise and industrial capabilities to deliver reliable, scalable solutions to healthcare systems worldwide, continuously expanding our capabilities across research, development and manufacturing.

Our work is guided by scientific rigor, quality and a clear purpose: improving global health by making reliable diagnostic and therapeutic solutions accessible to people everywhere.

To achieve this, we integrate the entire value chain — from R&D to final production — ensuring consistency, flexibility and impact in every solution we deliver.

Looking ahead, we aim to become a global reference in innovative biotechnological solutions, advancing diagnostics and nucleic acid-based therapies that transform patient care and support the evolution of healthcare systems.

Our approach is based on these principles, ensuring consistent performance, regulatory compliance and long-term value for our partners worldwide.

Human commitment

We work to improve people’s health and generate a positive global impact, driven by a shared purpose across our teams.

Scientific excellence

We advance through research, innovation and the integration of knowledge to deliver meaningful solutions to real-world challenges.

Operational strength

We combine vertical integration, adaptability and efficiency to respond with agility in a demanding and evolving environment.

Customer proximity

We build close relationships through active listening, personalized support and a deep understanding of our partners’ needs.

Integrity & compliance

We act with transparency, scientific rigor and full adherence to regulatory and ethical standards.

Quality Assurance

Our Quality Management System (QMS) is MDSAP certified, assessing compliance with ISO 13485:2016 and regulatory requirements of:
Canada | United States | Brazil | Australia | Japan

The monitoring of the MDSAP certification in 2024 and 2025 has been funded by the 2025 International Certification Aid Program of the Official Chamber of Commerce, Industry, Services and Navigation of Spain.

Our history

Our facilities

An area of more than 2,000m2 of usable ground and the possibility of expanding in more than 8,000m2, Certest Biotec new premises are designed for energy efficiency.

Photovoltaic solar installation of 99,7 kwp on the roof of Certest Biotec.

Co-financed Project by Economy, Industry and Employment Department of Aragon Government and by the European Regional Development Fund (FEDER 2014–2020), according to “public assistance for energy saving and diversification, rational use of energy and use of indigenous and renewable resources, and energy infrastructure”.

Global Regulatory Affairs

Regulatory expertise ensuring international market access and IVDR compliance

Sustainability

Committed to environmental, social, and corporate responsibility.

Talent Management

Highly qualified teams driving innovation, expertise and continuous development

Ethics Line

Corporate integrity, transparency and compliance across all business activities