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First in Human Feasibility Study (4 to 8 patients) conducted prior to ISO 13485 Certification

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Guest user Created:   Jun 23, 2020 Last commented:   Jun 23, 2020

First in Human Feasibility Study (4 to 8 patients) conducted prior to ISO 13485 Certification

Can a First in Human Feasibility Study (4 to 8 patients) be conducted prior to ISO 13485 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 Jun 23, 2020

You can conduct, prior to the ISO 13485:2016 certification, first in human feasibility study according to the Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/investigational-device-exemptions-ides-early-feasibility-medical-device-clinical-studies-including

This way you will be sure that your medical device has proper intended use and be sure that it is a medical device. After you get that approval, you can go to the ISO 13485:2016 certification. However, certain steps in this feasibility study will be covered by requirement 7.3 Design and development, so be sure that you have records of each step that is required. 

For more information on managing the design, please see the following link:

Also, you can see how records about design and development look lin in ISO 13485:2016 Documentation toolkit on the following link:

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Jun 23, 2020

Jun 23, 2020