German Institute for Standardization EN ISO 13485 Certificate

We understand ourselves us as quality oriented OEM service provider and partner of innovative solutions in the field of medical technology

This happens in close collaboration with our customers and accredited, admitted test bodies and authorities.

Certified Quality Management System

Technical demands are defined in interactive and narrow cooperation of our specialists with our customer and are checked at the same time for feasibility.

Though, process security and avoidance of unnecessary costs increase the customer use.

BYTEC works since 1996 with an entire quality management system, certified according to the German Institute for Standardization EN ISO 13485. Suitable processes are the basis of our everyday work and are supervised and optimized constantly also in view of the greatest possible advantage for our customers.

Our Manufacturing and your Security

The certification of our quality management system is one of the legal requirements for the development and production of your medical products. We observe the current demands of the European directives for medical product manufacturers and the national / international laws as well as the demands of the German Institute for Standardization EN ISO 13485.

Through the proved, certified internal processes we ensure the customer satisfaction from the product idea to the final product.

Besides, we are a FDA and UL registered manufacturer.

An integrated quality assurance accompanies goods and products from goods receipt to ready to dispatch of the finished device suitable to the specified product features.

Quality is not only a concept for us but our comprehensively lived company philosophy.

BYTEC Medizintechnik GmbH Hermann-Hollerith-Str. 11
D-52249 Eschweiler

Tel. +49 (0) 24 03 / 78 29 - 900
Fax +49 (0) 24 03 / 78 29 - 999

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