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Quality Management

Franz Kalff GmbH has been working according to certified quality management and quality assurance systems for over 20 years.

The head of our quality department, Mr. Christof Gehlen, whose experience includes 40 years with our company, accompanies all products from development to serial delivery together with his team.

Every year we are audited by an inspection company accredited by the Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG). Various other product inspections by independent institutes also prove the above-average quality of our articles.

We are constantly seeking improvements, as we are convinced that continuous improvement in particular is what prepares us for the future.

Our certifications help us with this systematic approach. They also allow us to publicly demonstrate what standards we gear our processes to.

We have certifications according to:

  • DIN EN ISO 13485
  • DIN EN ISO 9001
  • DIN EN ISO 14001
  • Quality assurance according to 93/82/EEC


The respective certificates are available from the Downloads section.