Quality

We operate our Quality Management System under ISO 13485:2016. The system is focused on the need of our customers in the field of medical devices. Our business processes are planned and controlled and continuously under improvement. Our employees are trained internally and externally in order to fulfill legal and normative requirements. We survey and document our production processes with state-of-the-art equipment. Our core processes are validated. Moreover we validate customer specific and product specific processes with internal or external specialists.

Quality Policy and Environmental Policy

Our organization is aligned to fulfil the customer need with regard to technical quality and for the well-being of the patient and the user of the products and services from us.

At the same time we aim for a profitable organization with continuous increase of competences through training and education. For this reason we train and educate our employees.

The selection of resources and processes is done in an optimal manner under economic and ecological aspects. Our organization aims to consider the use of natural resources e.g. water, air, biological diversity within all of its activities. In any way the protection of the patient or user of a medical device has always priority before environmental aspects.

The fulfilment of applicable laws and normative requirements is basis of our activities.

The application of Quality – and Environmental Management Systems und the continuous improvement of our organization and business processes in all areas of our company is part of our company policy.