D DavidHedfors Sep 1, 2014 #1 Sep 1, 2014 #1 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
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 Sep 2, 2014 #2 Sep 2, 2014 #2 Please provide more information. For what FDA branch or type of product (food, medical device...), on what subject?
Please provide more information. For what FDA branch or type of product (food, medical device...), on what subject?
D DavidHedfors Sep 2, 2014 #3 Sep 2, 2014 #3 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: Sep 2, 2014
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.
A ascherp Sep 2, 2014 #4 Sep 2, 2014 #4 I printed some of the chapters before the FDA withdrew them from their website. Any specific chapter you need or all of them?
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 Sep 3, 2014 #5 Sep 3, 2014 #5 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,
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 Sep 6, 2014 #6 Sep 6, 2014 #6 Chapter 3-5 and 9 Attachments MDQS_SECG_Chap3_Design_Control.pdf 150.4 KB Views: 181 MDQS_SECG_Chap4_Process_Validation.pdf 211.5 KB Views: 201 MDQS_SECG_Chap5_Personnel_and_Training.pdf 71 KB Views: 186 MDQS_SECG_Chap8_Device_Master_Record.pdf 159.1 KB Views: 159 MDQS_SECG_Chap9_Document_and_Change_Control.pdf 103.1 KB Views: 167
A ascherp Sep 6, 2014 #7 Sep 6, 2014 #7 That's all I have. Hope it helps! Attachments MDQS_SECG_Chap14_Storage_Distribution_Installation.pdf 83 KB Views: 136 MDQS_SECG_Chap15_Complaints.pdf 300.4 KB Views: 255 MDQS_SECG_Chap16_Servicing.pdf 232.1 KB Views: 139