As part of its implementation plan of the new European regulation on medical devices1, CareLine Solutions has obtained certification that its management system complies with the ISO 13485:2016 standard for the design, development and marketing of digital solutions in the context of medical care.
This certification, valid for 3 years and subject to an annual audit, was issued on 12 July 2023 by Bureau Veritas Certification France. It attests to the consideration of customer requirements, current regulations and the ability to understand new technologies and market opportunities.
The ISO 13485:2016 standard, specific to medical devices, takes into account the specific requirements of this field, in particular with regard to compliance with regulatory requirements, risk management and control, control of the design process and traceability.