ISO 13485 & EU MDR / Legal and statutory requirements associated with ISO 13485
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ISO 13485 DOCUMENTATION TOOLKIT
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The best way to start for legal and statutory requirements is the list of harmonized standards published by the European Union. These harmonized standards are applicable for different types of medical devices.
Here is the link to List of harmonized standards: https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en
For more information, please see the following articles:
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