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ISO 13485:2016
Medical devices - Quality management systems - Requirements for regulatory purposes
Content Provider
International Organization for Standardization [iso]
Others Also Bought
Quality management systems - Requirements
Medical devices - A practical guide
Medical devices - Application of risk management to medical devices
Document History
Revises:
- ISO 13485:2003
- ISO 13485:2003/Cor 1:2009
- ISO/TR 14969:2004
Included in Packages
This standard is also available in these packages:
- ISO 13485 / 14971 / 14969 - Medical Devices Package
- ISO 13485 / IEC 62304 / ISO 14971 - Medical Devices Package
- ISO 13485 / ISO 19011 - Medical Devices Regulatory Package
- ISO 13485 / ISO 9001 - Medical Devices Quality Management Set
- ISO 13485 and ISO 14971 - Medical Devices Package
- ISO 13485 and ISO/TR 14969 Quality Management Systems Medical Devices Package
- ISO 13485:2016 and ISO 13485:2003 - Medical Devices Transition Set
- ISO 9001 / ISO 13485 - Quality Management for Medical Devices Set
Amendments & Corrections
We have no amendments or corrections for this standard.
