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SOPs

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Guest user Created:   Jul 13, 2022 Last commented:   Jul 15, 2022

SOPs

Thanks for the link. I downloaded the demo kit. looks good! I have few questions: I didn't see any SOP for change control. How do you cover that? Do you have SOPs for the performance, monitoring etc. of clinical trials? In the training forms I didn't see a training verification check. Do you have it implemented in the process? If so, how?
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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 Jul 15, 2022

No, we do not have a Change control procedure per se. Change control is both covered in the Document management procedure and in the Management review. There is no strict requirement for the documented procedure in requirement 4.1.4 in the ISO 13485:2016. 

Clinical trials are not covered with this toolkit because there is no requirement in the MDR to be a part of the Quality management system (Article 10 Obligations of manufacturers, Point 9). We have in our toolkit the necessary documentation for clinical evaluation. 

In the Documentation toolkit, there is a record Appendix 2 Training record where performance monitoring is defined within 3, 6, and 12 months. 

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Jul 13, 2022

Jul 15, 2022

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