Legal and statutory requirements associated with ISO 13485
Am looking for the legal and statutory requirements associated with ISO 13485
Assign topic to the user
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
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:
- What are EU harmonized standards? https://advisera.com/13485academy/blog/2020/06/12/what-are-eu-harmonized-standards/
- How to determine regulatory requirements according to ISO 13485:2016 https://advisera.com/13485academy/knowledgebase/how-to-determine-regulatory-requirements-according-to-iso-13485/
Comment as guest or Sign in
Aug 20, 2020