Biotecno Scientific Refrigerators and Freezers passed the registration process with the U.S. Food & Drug Administration - FDA, federal agency of the United States Department of Health and Human Services. FDA certification, despite being North American, opens doors not only to the market in the United States, but in addition to other countries that require American certification, among which are European countries.
Conducted over several months, due to the rigor of the American regulatory agency, the certification process has been completed and represents a milestone for the company. “American FDA certification represents the possibility of introducing Biotecno product to other parts of the world”, says Lídia Linck Lagemann, Director and Administrative Manager of Biotecno.
In the United States, FDA certification is based on public health care. It ensures that medical devices intended for human use are safe and effective. The registration also represents a new level of equipment reliability for the Brazilian public, by using scientific equipment approved by one of the most demanding regulatory bodies in the world.
Biotecno conservation chambers are being widely used by the Brazilian health system to combat the current pandemic, for the correct and safe conservation of immunobiologicals, samples and research material. In Brazil, the equipment is registered with the Ministry of Health and produced according to ANVISA Good Manufacturing Practices. Company innovations, such as the creation of the Emergency System for conservation chambers, revolutionized the entire segment and made Biotecno the most awarded scientific refrigeration brand in the country.