Published : 09/14/2018 - Categories : News
Alsachim has obtained ISO 13485 certification for its in vitro diagnostic kits business, demonstrating the company's ability to meet regulatory requirements and its commitment to the quality of its medical devices.
This certification is a strategic step in the development and commercialization of diagnostic kits for immunosuppressants.
DOSIMMUNE™,which already benefits from the European CE-IVD certification obtained at the end of 2017, now has international accreditation for medical devices.
A recognized quality management system
The international standard ISO 13485 is intended for all companies whose business is related to medical devices. The latter specifies the requirements of quality management systems for the medical device industry. It certifies an organization for the conformity of its quality management system with the highest market and customer requirements.
Granted by BSI, ISO 13485 certification is the result of Alsachim's desire to demonstrate its commitment to the quality of its products and activities by meeting the requirements of the standard, but also those of its customers. It thus ensures the implementation of efficient traceability for the medical devices developed by the company; from the design of the product to its distribution and manufacturing.
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