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Ella Biotech GmbH | Am Kugelfang 39, D-82256 Fürstenfeldbruck | info@ellabiotech.com | +49 8141 36636-0

ISO 13485

The International Organization for Standardization (ISO) is a voluntary, non-governmental organization that provides unified standards for many different areas of industrial activity. The ISO 13485 designation is the standard for manufacturers of medical diagnostics. While similar to GMP in many respects, holding an ISO 13485 certification is not a legal requirement, but is accepted as an international standard. Manufacturers are continually audited and must be recertified on a regular basis. The regular audits ensure that the reported standards of manufacturing are maintained and encourage continuous improvements.
As of 2010 we have observed an increasing demand for high quality oligos for use in In Vitro Diagnostics. Therefore, Ella Biotech determined to obtain the ISO 13485 certification to provide proof that we have a system in place to validate and provide traceability for oligonucleotide manufacturing history during the production process. In May 2011 we were successfully certified by DQS under certificate registration no. “345862 MP23SCC” for “Development, Production and Distribution of Biopolymers for the use in In-Vitro Diagnostics”.
Together with our customers in human diagnostics, we define the oligo characteristics that will work best for their diagnostic applications. We provide guidance on process scale-up for deliverable yields of a few nmoles up to multiple grams. We also boast supplementary services such as dedicated purification columns, aliquoting and other custom packaging, and oligo mixture formulation.

ISO 9001

ISO 9001 is one of the most widely used management tools in the world today. It ensures that the company meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to a product or service. Our Quality Management System is certified by DQS under certificate registration no. “345862 QM08”. The certification applies to following activities: “Development, Production and Distribution of Biopolymers”.