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ISO 13485 / ISO 19011 - Medical Devices Regulatory Package
ISO 13485 / ISO 19011 - Medical Devices Regulatory Package (Save 10% off List Prices)
The ISO 13485 / ISO 19011 - Medical Devices Regulatory Package provides regulatory requirements for a medical devices quality management system. It is also supported with guidance on auditing a management system including the principles of auditing, managing an audit program and conducting management system audits.
ISO 13485 / ISO 19011 - Medical Devices Regulatory Package includes:
- ISO 13485:2016
- ISO 13485:2016 - Medical Devices - A Practical Guide
- ISO 19011:2018
- ISO/DIS 19011:2025
International Organization for Standardization [iso]