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ISO 13485 certification is relevant for all medical devices manufacturers and suppliers. The standard is harmonized with the Medical Devices Directive and IVD directive and describes requirements on quality management systems handling medical and IVD devices. ISO 13485 certification is not a requirement for selling medical devices in the EU. It is however recommended because compliance with ISO13485 renders an assumption of passing the approval process for the IVD and MDD Directives.
Benefits of the ISO 13485 quality management system certification:
- It is a globally recognized and appreciated management system;
- Facilitates meeting planned results in your production;
- Ensures meeting regulatory requirements, including risk analysis, clinical evaluation etc.;
- Allows focus on process performance and effectiveness;
- Enables with continuous improvements.