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Certification qualification

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Guest user Created:   Feb 04, 2021 Last commented:   Feb 08, 2021

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.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Feb 08, 2021

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:

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Feb 04, 2021

Feb 08, 2021