DIN EN ISO 13485 – Quality management system

The quality of a medical device has a direct impact on the efficacy of the device and the safety of patients, users and others. This applies for medical products probably more than for any other kind of device. Therefore, manufacturers and suppliers of medical devices need to prove that they have implemented a quality management system that has been tested and certified by an independent body.

MedTec Medizintechnik GmbH is of course certified according to DIN EN ISO 13485.

TÜV Certificate

DIN EN ISO 13485

The standard DIN EN ISO 13485 "Medical devices: Quality Management Systems – Requirements for Regulatory Purposes" deals with the requirements that manufacturers and suppliers of medical devices have to meet when developing, implementing and maintaining management systems in the medical device industry. Originally developed in the 1990s, the standard contains regulations for quality management systems that fulfill the demands of customers as well as the European Union (EU), Canada and other important markets worldwide.