Looking for the FDA's Small Entity Compliance Guide

D

DavidHedfors

I?m looking for the Small Entity Compliance Guide, about 20 pages as I remember it. Not the 468 page Manual. Does anyone have a copy of that guide?

Thanks
 
A

ascherp

Please provide more information. For what FDA branch or type of product (food, medical device...), on what subject?
 
D

DavidHedfors

Sorry, I meant my post as a reply to this thread:

elsmar.com/Forums/showthread.php?p=557897#post557897

QSR for Medical Devices is the subject I?m interested in.
 
Last edited by a moderator:
A

ascherp

I printed some of the chapters before the FDA withdrew them from their website. Any specific chapter you need or all of them?
 
D

DavidHedfors

Right now I?m looking for Documentation guidelines, but from past experience, I need to consult this guide about once a month. If you can upload all of it, I would be grateful.

Thanks,
 
A

ascherp

Chapter 3-5 and 9
 

Attachments

  • MDQS_SECG_Chap3_Design_Control.pdf
    150.4 KB · Views: 203
  • MDQS_SECG_Chap4_Process_Validation.pdf
    211.5 KB · Views: 258
  • MDQS_SECG_Chap5_Personnel_and_Training.pdf
    71 KB · Views: 213
  • MDQS_SECG_Chap8_Device_Master_Record.pdf
    159.1 KB · Views: 166
  • MDQS_SECG_Chap9_Document_and_Change_Control.pdf
    103.1 KB · Views: 190
A

ascherp

That's all I have. Hope it helps!
 

Attachments

  • MDQS_SECG_Chap14_Storage_Distribution_Installation.pdf
    83 KB · Views: 155
  • MDQS_SECG_Chap15_Complaints.pdf
    300.4 KB · Views: 282
  • MDQS_SECG_Chap16_Servicing.pdf
    232.1 KB · Views: 148
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