phone: +49 2354 92950

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Quality management and

regulation

We are your specialist when it comes to regulatory requirements for manufacturers and suppliers of partial components or fully packaged medical products.

DIN EN ISO 13485

Our conscious step towards certification according to DIN EN ISO 13485 shows our commitment to the highest standards in medical technology. DIN EN ISO 13485 goes far beyond the requirements of other quality management systems such as DIN EN ISO 9001, particularly in the areas of product safety, production environment and risk management, and at the same time places great emphasis on quality control and continuous improvement. In addition, we meet the requirements for listing as a critical supplier in terms of both the European Medical Device Regulation (MDR, EU Regulation 2007/745) and the US FDA, which is required for medical technology approvals. We would be happy to offer you our know-how to support you in your approval processes.

Quality, reliability and compliance

If you are looking for quality, reliability and compliance in medical technology, we are your partner of choice. Trust our expertise and commitment to meet your needs. Contact us today to find out more!

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  • Messtechnik und Kontrolle
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Our certificates for download

Medical technology IQ-net

EN ISO 13485 IQ NET

Download

EN ISO 13485

Download

ECOPROFIT AWARD

Download

PRIVACY CERTIFICATE

Download

ENERGY ADVICE ACCORDING TO DIN EN 16247-1

Download

CODE OF CONDUCT

Download

Further questions about our expertise?

Jonas Wintersohle

Head of Technical Sales
+49 (0)2354 9295102 | j.wintersohle@tebit.de

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