Awards and Certifications

Certifications

Made in Germany

The certified proof of origin trademark „Made in Germany“ ensures that:
• the major part of production is done in Germany ,
• the value-added share is generated in Germany,
• quality assurance is monitored according to German norms and standards .

DIN EN ISO 9001:2008

EN ISO 9001 regulates the minimum requirements for a quality management system for any organization providing products and services. It ensures that these products and services meet both customer requirements and regulatory guidelines. The norm also entails a continuous improvement process regarding the company’s management system.

DIN EN ISO 13485:2012

ISO 13485 specifies the requirements for the design and manufacture of medical devices, with a special focus on product safety. The effectiveness of established processes is designed to ensure compliance with product requirements.

Bildungsidee

Die Protzek GmbH nimmt regelmäßig an öffentlichen Ausschreibungen teil.

Standort Deutschland

Die Protzek Gesellschaft für Biomedizinische Technik trägt das Standort Deutschland Siegel. Dies bedeutet, dass mindestens 70% der Wertschöpfung hier vor Ort geschehen.

RiliBÄK (Richtlinien der Bundesärztekammer zur Qualitätssicherung laboratoriumsmedizinischer Untersuchungen)

Protzek ermöglicht richtlinienkonformes Arbeiten (RiliBÄK) mit sogenannten Schnelltests bzw. in der patientennahen Sofortdiagnostik. (Unit Use-Reagenzien).

Innovation Award

In 2010, we have been awarded the Rudolf Eberle Innovation Award of the state of Baden-Württemberg. In cooperation with our partners and supported by public funding, we have developed opto-electronic devices and technologies for the semi-quantitative and qualitative measurement of test responses.

These devices and technologies, and their unique ability to provide documentation of results, help users to work in compliance with official guidelines (e.g. RiliBÄK) even with so-called rapid tests or in point-of-care diagnostics (Unit Use Reagents).

Read more about the award