Châtillon, France – Monday 14 October 2014 – TRIBVN, the European leading provider of medical imaging solutions for laboratory, has been granted for the ISO 9001:2008, ISO 13485:2003 and ISO 13485:2003 CMDCAS certifications.
TRIBVN has demonstrated that its processes – design and development, sales, production and customer service – are fully compliant with the regulations defined by the International and European standardization authorities.
The certification audit was conducted by the independent Notified Body G-MED. “Receiving these certifications demonstrates the capability of TRIBVN in developing medical software according to safe and robust internal processes, compliant with regulatory requirements. The ISO certifications are the result of a long-term work in implementing a quality management system and they confirm our continued commitment to provide our customers with the high-quality products that are needed,” said Aurélie Sager, TRIBVN Quality Manager. The ISO 13485 certifications ensure customers that TRIBVN medical devices are developed according to standardized processes that take patient safety into account.
Jean-François Pomerol, TRIBVN Director said: “Certification is a key step for TRIBVN. It allows us to address new markets thanks to a reinforced internal organization and to products compliant with customers’ requirements and regulatory”. Thanks to these certifications, TRIBVN is now able to extend the CE-IVD marking of its solutions towards diagnosis. Jean-François Pomerol concluded: “The digital pathology will be more and more used in clinical routine. We must provide software which enable our customers to perform an efficient, safe and faster diagnosis”.