@@EasyMedicalDevice True! I was thinking about the alterations she mentioned, like raw materials, and the new evaluation and biological evidences, etc. So, I understood that you will define which tests you should (or not) apply on your Medical Device according the characterisation of the raw materials and substances on it, as well as the characterisation of the medical device itself (patient contact, direct or indirect use, contact time, etc), is that it ?
![How to create your Medical Device Technical File [EU MDR & IVDR]](http://i.ytimg.com/vi/2cHbr5VGhSI/mqdefault.jpg)
![How to create your Medical Device Technical File [EU MDR & IVDR]](/img/tr.png)
Thank u so much
Is there same video for clinical evaluation ?
Yes we have made few of them with Cesare Magri, Ed Drower, Helene Quie...
@@EasyMedicalDevice okey I will check them
Thank u for your efforts :)
Thank you so much for this video...... really was very informative.......Great Respect from India
Is all this information in the Device History Record?
I think this is more on the Device Master File DMR for US dossier. Or on the Technical Documentation for EU market
@@EasyMedicalDevice True! I was thinking about the alterations she mentioned, like raw materials, and the new evaluation and biological evidences, etc. So, I understood that you will define which tests you should (or not) apply on your Medical Device according the characterisation of the raw materials and substances on it, as well as the characterisation of the medical device itself (patient contact, direct or indirect use, contact time, etc), is that it ?
@@vanessaandrade4858 the most important is duration of contact, area of contact… with ISO 10991-1 you will see what test ro do
@@EasyMedicalDevice Thank you so much! I will check it out. :D