As a healthcare provider, a secure and functioning quality management system is also of paramount importance to us as a company.
On the one hand, the authorities are setting ever higher requirements that we have to meet. On the other hand, we also want to be able to ensure that our customers receive products of the highest quality. Because in the end, the goal of all of us is safe and fair care for patients. Here, only products of the very highest standard should be used to ensure smooth operation.
Our internal structures, in combination with monitoring by external certification bodies, ensure that our safety and monitoring processes run smoothly.
In 1995 we introduced our QM system. servoprax GmbH is certified in accordance with DIN EN ISO 13485:2016 for the development, procurement, assembly, storage, distribution and final inspection of medical devices and consumables, rehabilitation and orthopaedic products and products for emergency medicine.
Through the supervision of the Notified Body mdc medical device certification GmbH, Stuttgart this QM system is checked and confirmed in regular audits. The Quality Management Team in-house is responsible for maintaining the QM system and is the contact for all QM questions
Safety and monitoring
- Quality management system
- Supervision of certified medical devices
- Certified according to DIN EN ISO 13485:2016
The cleanroom production is certified for the following:
- Manufacturing and distribution of catheter sets,
- Packaging of medical devices under cleanroom conditions,
- Manufacture of system and treatment units,