News
CRITICARE, February 15-19, Pune, India
January 24 2012
Conference on Continuous Renal Replacement Therapies (CRRT), February 12-15, San Diego, USA
January 24 2012
MEDLAB, Arab Health, January 23-26, Dubai, UAE
January 16 2012
An addition to the Obesity and Type 2 Diabetes antibody portfolio
December 22 2011
Better kidney markers ahead?
December 05 2011
New NGAL.com website launched
November 24 2011
MEDICA, November 16-19, Düsseldorf, Germany
October 26 2011
ASN Kidney Week, November 8-13, Pennsylvania, Philadelphia, USA
October 20 2011
ESICM 2011, October 1-5, Berlin, Germany
September 06 2011
AACC Clinical Lab Expo, July 24-28, Atlanta
July 04 2011
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.
