Quality System and Regulatory Affairs

Biological Industries products are intended for use in life science research and applications. With respect to regulatory requirements, the products are divided into two groups:

Quality System

The Biological Industries Quality System complies with the quality management standard ISO 13485:2003 and is routinely audited by an accredited external body.

ISO 13485:2003 certification is available upon request.

Products for research use:

Products for research use are mainly those intended for molecular biology and others that are not included in the “In Vitro Diagnostics” category. These products are prepared according to the requirements determined by Biological Industries.

Products for In Vitro Diagnostics:

The products for In Vitro Diagnostics are produced according to the “In Vitro Diagnostics Directive 98/79/EC“ of the European Parliament. As such, the products bear a “CE” mark for “In Vitro Diagnostic Use”.

These products are considered medical devices, but are also suitable for research use and as raw material components in further manufacturing processes.

Declarations of Conformity for in vitro diagnostic products are available upon request.

Serum Products:

Biological Industries holds certification from the European Directorate for the Quality of Medicines (EDQM) regarding safety from the possibility of BSE contamination in our sterile foetal bovine serum.

Certification is available upon request.