Alsachim has obtained the renewal of its ISO 13485 certification for its activity as a manufacturer of in vitro medical devices. The renewal of this certification is recognition of our commitment to the quality of our products and associated services, and our ability to comply with regulatory requirements.

ISO 13485, a guarantee of quality management for Alsachim's medical devices

Alsachim obtained its 1^st certification in 2018 (read the article). The renewal of this certification therefore confirms the quality of the processes implemented by the company and its teams to design, develop and make available medical devices that meet regulatory requirements. Indeed, the international standard ISO 13485:2016 “Medical devices - Quality management systems - Requirements for regulatory purposes” establishes strict quality management requirements for medical devices.

As a manufacturer of in vitro diagnostic kits, this certification is a recognition of our teams' commitment and investment in providing quality products and services, in line with Alsachim's vision and values.

Download Alsachim's ISO13485:2016 certificate