Quality management system audit
Synbase successfully passed the quality management system audit based on the ISO 13485:2016 standard.
On August 25, 2022, the Belgian branch of BSI (British Standards Institution) recognized Synbase as meeting the requirements set for the quality management system. To confirm this, a certificate with the number MD 764793 was issued. The certificate proves the company’s commitment to the production of high-quality medical devices.
High quality medical devices
ISO 13485:2016 is an international quality management system standard for the medical device industry. The requirements of the standard apply to organizations that must demonstrate their ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Scope
Synbase meets the requirements of the ISO 13485:2016 standard in the following areas: design, development, production, sales, distribution, installation and service of clinical decision support system software related to medicines.
