Quality and Safety

Given the importance of patient safety, quality and functionality, all endoscopes are assessed by an independent quality department both before and after repair, which ensures high-quality repairs.

The incoming and outgoing inspection of all flexible and rigid endoscopes follows a fixed protocol that is part of our quality management system. 

ISO certification

To guarantee safety and quality for your patients, Althea Nederland is ISO certified.

 

    Medical Devices – Quality management systems –
    Requirements for regulatory purposes 

 

   

       Quality management systems – Requirements 

You can download our certificates here.

MDR - Regulation (EU) 2017/745

Althea Nederland B.V. declares to comply with the requirements set out in Regulation 2017/745 (MDR) where applicable to its activities.

 

Should you require further information, please let us know.