News
ESICM 2010, October 10-13, Barcelona, Spain
September 10 2010
Expansion of the peptide hormone antibody portfolio
August 23 2010
Product launch: Pig NGAL ELISA Kit (KIT 044)
August 12 2010
AACC/Clinical Lab Expo 2010, July 27-29, Anaheim, CA
July 06 2010
IUTOX 2010, July 19-23, Barcelona, Spain
June 30 2010
BioPorto Diagnostics at the ERA-EDTA Congress, Munich, June 25-28
June 14 2010
BioPorto Diagnostics at APCN 2010, June 5-8, Seoul, Korea
May 21 2010
Presentation of The NGAL Test data at the BRS/RA Conference, May 17-20, Manchester, UK
May 14 2010
Product launch: new monoclonal antibodies available
May 07 2010
Presentation of The NGAL Test data at the 30th International Symposium on Intensive Care and Emergency Medicine (ISICEM)
February 22 2010
BioPorto Diagnostics obtains Quality Management Certification
February 18 2010 by Ana Belén Enfedaque Buisán
In February 2010, BioPorto obtained ISO 13485:2003 certification of its quality management system. Being certified means that a notified body, in BioPorto’s case KEMA Quality B.V., has assessed the Company’s processes and documentation and found them to be in compliance with device GMP.
Obtaining this certification is an important prerequisite when registering own products in markets such as China, Brazil and Russia. BioPorto has also obtained ISO 13485:2003 certification under CMDCAS (Canadian Medical Device Conformity Assessment System) which enables BioPorto to take over the existing licenses for diagnostic ELISA kits in Canada, thereby gaining more control in this market.
Furthermore, the certification is a strategic element in becoming an approved supplier to large diagnostic companies, who require reliable and regular deliveries.
