ISO 13485 - General Requirements For Medical Devices

ISO 13485

ISO 13485 - General Requirements For Medical Devices

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.

Your benefits with ISO 13485 certified products

Full documentation and traceability of production processes
Provision of technical documentation
Design & Development
Risk Management
Change management
Error management
Health protection, occupational safety and hygiene

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:

Pharma & Diagnostics

Manufacturing of medical devices (MD) or in vitro diagnostic products (IVD)
Manufacturing of reagents or substances for use in IVD or MD

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The ISO 13485 standard is applied to the following Eurofins Genomics processes:

Literature

ISO 13485 - General Requirements For Medical Devices (eurofinsgenomics.eu)

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Our products and services are produced and performed under strict quality management and quality assurance systems.

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