Certification qualification
If a company does not existingly have a medical product in its production, does it qualify for certification?
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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
According to section 1. Scope of the ISO 13485:2016 is stated that this standard is applicable to all entities involved in the life-cycle of the medical device. It means that this standard is applicable for: manufacturer, design and development, storage, distribution, installation, service, or any other company that provides associated activities like technical support.
For more information about ISO 13485, please see the following articles:
- What is ISO 13485? https://advisera.com/13485academy/what-is-iso-13485/
- Six key benefits of ISO 13485 implementation https://advisera.com/13485academy/knowledgebase/six-key-benefits-of-iso-13485-implementation/
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Feb 08, 2021