2 About us 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 control 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 About Albert Kerbl GmbH Albert Kerbl GmbH is an international manufacturing and wholesale company based in Buchbach (Mühldorf/Inn district, Bavaria) offering a range of supplies that is unique in Europe, wide-ranging, powerful and always in line with current trends. We look forward to receiving your queries and feedback. Your KERBL team
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