Châtillon, France – Friday 7 July 2017 – TRIBVN Healthcare obtains the renewal of its ISO 13485 : 2016 and ISO 13485 CAMDAS Certifications
TRIBVN Healthcare successfully passed the external audit conducted by the independent Notified Body LNE G-MED for the renewal of its 13485 certifications. The 13485 certifications describe the requirements for a comprehensive quality management system for the design and distribution of medical devices.
“The goal of the audit this year was to renew the initial certifications obtained in 2014 but also to verify that the company has adapted its processes to the 2016 version of the norm that will be mandatory at the later in 2019” said Rathiga Puganenthiran in charge of Quality and Regulatory.
The renewal by LNE G-MED of the ISO 1385 certifications is a proof of the ability of TRIBVN Healthcare to maintain a quality management system that complies to regulatory requirements and to implement processes that guarantee reliable and sustainable solutions for its customers.
Jean-François POMEROL, Managing Director said: “ISO Certifications is a great satisfaction and a recognition of the work done by the team. It is a demanding certification, internationally recognized, which facilitates the registration of our software as medical devices both in Europe with CE marking and in Canada. It is today a necessity for the design of solutions in digital pathology for diagnostic procedures.”