October 15th , 2020 . Besançon
Archeon obtains ISO 13485:2016 certification

“Obtaining ISO 13485:2016 certification is an important step for Archeon.”

“It is an essential instrument to meet regulatory requirements and shows the company’s determination to be part of an industrial approach that meets the highest standards of safety, performance and reliability” explains Alban DE LUCA, CEO and co-founder of Archeon.

“Archeon is a company with high growth objectives. The quality management system that has been certified is the result of 2 years of intensive work by the whole team led by our Quality Manager, Valentine OQDA.

The result of a team work

Our quality management system reflects our Quality Policy and is articulated around three main axes:

  • Satisfy the requirements and expectations of our customers by ensuring that the products developed bring a high added value and guarantee a strong usability which is often considered as critical in the field of emergency care;
  • Guarantee safe products for our customers and their patients by placing the risk management at the heart of our attention and meeting all the regulatory and normative requirements applicable to our products;
  • Maintain the integrity, image and reputation of the company.

The certification covers the global activities of Archeon for the development, manufacturing and sale of medical devices for cardio-pulmonary resuscitation and provides the company with strong basis for the deployment of innovative solutions.”

Next news