Dentegris

Quality made in Germany

Quality

Fulfilling the regulations in medical technology is not only a requirement, but also a real challenge for anyone who is not deeply involved in the topic on a daily basis. Meeting regulatory requirements that are becoming increasingly complex every year requires specific specialist knowledge and a lot of work.

Dentegris works with a certified quality management system in accordance with the regulations RL93/42 EWG and EN ISO 13485 for the development, manufacture and distribution of medical devices.
From our point of view, the certification of our company “only” creates the conditions for being able to produce quality.

Precision is our passion. We live quality without ifs and buts. With well-trained teams of employees and safe, efficient processes and, of course, our personal quality standards, we continually implement what is most important to us: ensuring our customers are 100 percent satisfied in the long term.

All employees have made this their task and obligation; Only in this way and together can the desired quality be delivered “without ifs and buts”.

Our products undergo the strictest quality controls. This starts with the selection and procurement of raw materials and ends with the final inspection of each part under the microscope.

Meeting the highest customer requirements is based on clear specifications and processes, the traceability of which leads to reproducible quality at all times. Special know-how and the most modern machine and system technologies ensure the constant, reliable implementation of our quality standards.

Our company is certified according to the following regulations:

DIN EN ISO 13485:2016

Quality management system for medical devices

PDF/467KB

DIN EN ISO 13485:2016

Quality management system for medical devices

PDF/6.6MB

RL93/42 EEC

Medical Devices Directive

PDF/319KB

RL93/42 EEC

Medical Devices Directive

PDF/319KB

en_GB