Kerbl Medical Device Manufacturer

Bild für Kerbl Medizinprodukte
With the implementation of a quality management system according to EN ISO 13485:2016 for medical devices along the entire supply chain, KERBL is now able to put Class 1 Medical Devices on the market and serve new customer groups with those kind of products. The quality management system according to ISO 13485:2016 ensures that KERBL fulfills Regulation (EU) 2017/745 throughout Europe and that the affected products meet the high requirements in terms of quality and reliability for medical devices.

I.e. for Kerbl this means:
  • Registration in the European database for medical devices EUDAMED as a manufacturer (SRN No.: DE-MF-000007708) and in the German medical devices information system (MPS) of the Federal Institute for Drugs and Medical Devices (BfArM)
  • Regular audits at production facilities and at Albert Kerbl GmbH
  • Documentation of the quality checks of each individual batch at production facilities and at KERBL 
  • Consistent batch tracking from production to the customer
  • Introduction of a complaints management system for medical devices at KERBL
Find out more about our medical devices here.