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Technical File for Surgical Mask in Class 1 MDD

S

SG_777

Registered
#1
#1
Hi All,

I am looking for my company product surgical mask, CE Mark. I need technical file for a surgical mask for MDD class 1. Kindly share some sample/draft word files how to write technical file for surgical mask.

Is someone can write for me, Let me know your cost.
Thanks
 
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WAQAR-QMS

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#2
#2
Yes.
You need to follow PPE Standard for EU (2016/425).
In addition with harmonized and new introduced requirements.
Either what its risk class or what purpose it will serve, You need to setup a comprehensive requirements.

Let me know if i can be of more assistance.
 
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