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
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.