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ISO 13485 Certification
GMP Oligonucleotides For IVD And ASR Applications By Eurofins Genomics
Oligonucleotides according to medical devices standard and directive.
ISO 13485 defines all general requirements for "Medical Devices - Quality Management Systems Requirements" for regulatory purposes. It applies to manufacturing or assembly of medical devices (MD), of in vitro diagnostic products (IVD) and reagents or substances for use in IVD or MD.
Achieving compliance with European regulatory requirements with ISO 13485
Your benefits with ISO 13485 certified products
Key requirements of ISO 13485
ISO 13485 focuses strongly on the compliance of manufactured products and production processes with EU directives for MD or IVD such as:
The compliance with ISO 13485 is achieved through certification by an approved certification body and independent internal audits.
Eurofins Genomics is committed to delivering products, services and applications that are at the highest quality.
ISO 13485 is the basic standard for the following applications:
The ISO 13485 standard is applied to the Eurofins Genomics service offering in the field of DNA & RNA oligonucleotides: