Product specific change notifications for our clinical products

Miltenyi Biotec strives to provide clinical products meeting the highest standards. Therefore, we are constantly monitoring our quality and manufacturing processes. In order to always use the most up-to-date and compliant manufacturing processes, occasional changes in some of these processes can occur. 

Changes for products are in alignment with our change control process, are documented, and traceable. If applicable, we perform risk analyses, before implementing the change. One results of these analyses is to determine if a change notification is issued. However, some product changes always require the publication of a change notification.

Please find below some examples that may be subject to a customer notification: 

  • Change of critical raw material
  • Change of specifications
  • Change of manufacturing site
  • Change of label and/or packaging material 

This process applies to all products manufactured under the ISO 13485 quality management system covered in the Miltenyi Biotec Change Control SOP. 

To retrieve all applicable change notifications issued after January 1, 2021, simply enter the product number of your products of interest in the field below and receive a PDF download. 

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