RENNES, FRANCE— April 2, 2021
Diafir, a medical technology company focused on the development, manufacture and sale of innovative diagnostic solutions, today announced that it received the International Organization for Standards (ISO) 13485:2016 Quality Management System certificate from notified body BSI Netherlands, after their successful audit in December 2020.
“We are pleased to have achieved this voluntary milestone for our Quality Management System,” said Diafir’s CEO Hugues Tariel. “ISO 13485 certification is an important step in ensuring that Diafir maintains the highest standards for the design, development, and manufacture of our in vitro diagnostic medical device, and signals our commitment to quality to our customers. Being certified with one of few IVD notified bodies puts Diafir in the best position to succeed its transition to 2017/746 IVD regulation in the years to come.”
The ISO 13485 standard has been authored and influenced by the major medical device regulatory bodies across the world. As such, ISO 13485 is an internationally agreed upon harmonized and voluntary standard which defines a way to address common regulatory concepts and is an accepted approach with regulators to provide assurance that a company meets certain quality management system expectations defined within the standard.
The 2016 version of the international standard is a major revision of the 2003 version, with a heavy focus on risk management and risk-based decision-making processes at both the quality management system and product levels.
The validity of this ISO 13485 certificate is for a period of three years from the company’s last certification date to February 28th, 2024.