Quality Standards

Share

We are dedicated to bringing quality services to our clientele. We maintain our quality standards to always meet and adapt to local and regulatory policies. At BioAro, we can demonstrate that we have a top-notch quality management system, that we manufacture and distribute medical devices to the required standard, and that we have the required level of competency to have our laboratories accredited – all of which are regularly audited by independent certification bodies.

ISO 13485:2016

This standard addresses quality management for medical device design, production, and distribution. It helps us in maintaining and enhancing the quality of our medical devices and associated services, while meeting regulatory standards.

ISO 15189:2012

This standard addresses accreditation for medical diagnostic facilities. It aids in standardizing processes, procedures for quality systems, and technician specs in labs. Ensures high standards and compliance with health and safety regulations.