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Legal and statutory requirements associated with ISO 13485

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Guest user Created:   Aug 19, 2020 Last commented:   Aug 20, 2020

Legal and statutory requirements associated with ISO 13485

Am looking for the legal and statutory requirements associated with ISO 13485

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Aug 20, 2020

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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Aug 19, 2020

Aug 20, 2020