SENSDX SPÓŁKA AKCYJNA

- Developing and implementing a quality management system that adheres to the IVDR's requirements (as per Annex I, section 3 of the IVDR); - Preparing and maintaining technical documentation for the IVDs; - Conducting conformity assessment procedures to demonstrate the IVDs meet the IVDR's essential safety and performance standards. - Preparing and issuing a declaration of conformity that states the IVDs comply with the IVDR; - Establishing and maintaining a robust PMS system;

- Quality Representative Manager - Developing and implementing a quality management system that adheres to the IVDR's requirements (as per Annex I, section 3 of the IVDR); - Preparing and maintaining technical documentation for the IVDs; - Conducting conformity assessment procedures to demonstrate the IVDs meet the IVDR's essential safety and performance standards. - Preparing and issuing a declaration of conformity that states the IVDs comply with the IVDR;