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. QMS (quality management system) requirements are very similar to ISO 9001.
Achieving compliance with European regulatory requirements with ISO 13485
Your benefits with ISO 13485 certified products
- Full documentation and traceability of production processes
- Compliance with regulatory requirements in regard to EU, US and other national directives about medical devices (MD), in vitro Diagnostics (IVD) or medicinal products
- ISO 13485 compliant quality management system (QMS) is in line with the Food and Drug Administration’s (FDA) QSR standards
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:
- Provision of technical documentation (medical device file / technical product file)
- Specific design & development requirements
- Labelling, packaging and installation
- Sterile MD / IVD
- Implementation of a risk management process
- Health, safety and staff hygiene requirements
- Change management, market observations and procedures for product recall
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
The ISO 13485 standard is applied to the Eurofins Genomics service offering in the field of DNA & RNA oligonucleotides: