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Procedure for clinical trials

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Guest user Created:   May 27, 2020 Last commented:   May 27, 2020

Procedure for clinical trials

I am looking through the kit and I have not been able to find a procedure for clinical trials

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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 May 27, 2020

Yes, you are right. Unfortunately, in our toolkit there is no procedure for clinical trials because, in MDR 2017/745, requirements for documents for clinical investigation are very detailed described in Article 63, Article 72, and in Annex XV (Chapter II and III). Further on, clinical trials must be performed according to harmonized standard ISO 14155:2011 Clinical investigation of medical devices for human subjects — Good clinical practice. In most cases, clinical trials are conducted by specialized companies. 

Which documents are necessary for medical devices you can find in the following material: 

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May 27, 2020

May 27, 2020

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