Quality Standards

Biocientífica S.A. commits to the continuous improvement of the quality of its products and processes, complying with the regulatory requirements and international management standards and providing an adequate service of technical advice.

  • GMP. The company complies with GMP standards (Good Manufacturing Practices) that guarantees the quality, safety and efficacy of our products.
  • CE marking. The majority of our manufactured products are CE marked, following the quality standards of the European Union. Authorized Representative in Europe before Regulatory Authorities of the European Union: Medical Technology Promedt Consulting GmbH (St. Ingbert, Germany).

Biocientifica S.A.’s Quality Management System has the following scope:

  • Design, development, manufacturing, fractioning and conditioning of products for in vitro diagnostic use.
  • Distribution and sale of “in vitro” diagnostic products and laboratory equipment with its technical service.