Kerbl as medical device manufacturer

With the implementation of a quality management system according to EN ISO 13485:2016 for medical devices along the entire supply chain, Albert Kerbl GmbH 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 Albert Kerbl GmbH 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.

In concrete terms, this means for Albert Kerbl GmbH:

• Registration in the European database for medical devices EUDAMED as 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 in the production facilities and at Albert Kerbl GmbH
• Documentation of the quality inspection of each individual batch in the production facilities and at Albert Kerbl GmbH
• Consistent batch tracking from production to the customer
• Introduction of a complaint management system for medical products at Albert Kerbl GmbH