Quality excellence and compliance with all pertinent statutory, regulatory and legal requlations underpins our operations. Omega Diagnostics Ltd holds MDSAP and ISO 13485:2016 certifications, aligning with Directive 98/79/EC for In Vitro Diagnostic Medical Devices and The In Vitro Medical Devices Regulation (EU) 2017/746 (IVDR . 

A strategic commitment to continuous improvement is the foundation of our entire organisation, with every team member empowered to contribute to our quality management processes supported by a focus on optimising customer satisfaction in respect of our products and services.

To access our quality documentation, please register here.

For further information, please contact us at support@omegadx.com