BIOTÉCNICA,

The first national IVD industry

certified ISO 13485:2003 - Health Products - Quality Management Systems - UL Requirements.

This represents the commitment of the BioTécnica in:

• Develop
• Manufacture and
• Commercialize products of the highest quality level.

INNOVATION AND QUALITY

Walking together to offer you yhe Excellence in IVD products

The BIOTÉCNICA INDÚSTRIA E COMÉRCIO LTDA. was recently approved by Underwriters Laboratories Inc. (UL) in the ISO13485:2003, improving the range of quality assurance certifications, joint to ISO 9001:2000, obtained in 14 June 2002 and Good Manufacture Practice - GMP (BPFC-ANVISA) in 2005.

The main objective of the ISO 13485:2003 is to facilitate the harmonization of the requirements of the Quality Management Systems for Health Products.
As a result, it also includes some additional specific requirements for the IVD field.
The search for excellence is transcribed in the companies mission:
“Research, develop, manufacture and commercialize products attending to the IVD field with excellence and gaining, respecting and valorizing the life and the ethic relationships”

The approval in this certification is a confirmedness of the company’s ability in supplying the related products and services, according to the customers and regulatory requirements.