Medical Device Courses | Fady Khalla | Mentions https://medicaldevicecourses.com/members/fgk4/activity/mentions/ Activity feed mentioning Fady Khalla. Fri, 24 Apr 2026 21:55:29 -0400 https://buddypress.org/?v= en-US 30 hourly 2 23e7e08f888c64b2d46f11e6f110c162 cem34 replied to the topic "how far is "As Far As Possible"" - https://medicaldevicecourses.com/activity/p/23982/ Fri, 12 Nov 2021 18:21:32 -0500 Posted by: @fgk4 The ISO 14971:2012 “Risk management for medical devices” requires manufacturers to reduce risk As Far As Possible without any economical consideration. I consider this a huge Conundrum for all medical device manufacturers. It is a gray area…   Read more»

]]> 535cdac99d293c204ee45da62cc57ae1 jailynp26 replied to the topic "how far is "As Far As Possible"" - https://medicaldevicecourses.com/activity/p/23601/ Tue, 05 Oct 2021 00:22:29 -0400 Posted by: @fgk4 The ISO 14971:2012 “Risk management for medical devices” requires manufacturers to reduce risk As Far As Possible without any economical consideration. I consider this a huge Conundrum for all medical device manufacturers. It is a gray area…   Read more»

]]> 636ffafdf81ddffca0d4131054fc6b14 mejefferson replied to the topic "how far is "As Far As Possible"" - https://medicaldevicecourses.com/activity/p/23598/ Mon, 04 Oct 2021 15:30:22 -0400 Posted by: @fgk4 The ISO 14971:2012 “Risk management for medical devices” requires manufacturers to reduce risk As Far As Possible without any economical consideration. I consider this a huge Conundrum for all medical device manufacturers. It is a gray area…   Read more»

]]> bf3b2da16dbdeca093d79ae4dfa07f92 rajamharrison replied to the topic "When is validation is not required?" - https://medicaldevicecourses.com/activity/p/23550/ Sat, 02 Oct 2021 17:44:03 -0400 Posted by: @fgk4 As we all have learned this week, a validation may not be required if:- There were no changes required to the product after verification.- A clinical trial is not required- Product changes did not affect the user…   Read more»

]]> c783d06eecc555e42b3a640af7a77d7f arianaburch replied to the topic "When is validation is not required?" - https://medicaldevicecourses.com/activity/p/23545/ Sat, 02 Oct 2021 16:21:22 -0400 Posted by: @fgk4 As we all have learned this week, a validation may not be required if:- There were no changes required to the product after verification.- A clinical trial is not required- Product changes did not affect the user…   Read more»

]]> 097a2c12d42119c8a149ff3ded4753f9 mejefferson replied to the topic "When is validation is not required?" - https://medicaldevicecourses.com/activity/p/23510/ Mon, 27 Sep 2021 20:38:41 -0400 Posted by: @fgk4 As we all have learned this week, a validation may not be required if:- There were no changes required to the product after verification.- A clinical trial is not required- Product changes did not affect the user…   Read more»

]]> 821c7476d318f350da8a2cf29832247c JordanKayal replied to the topic "how far is "As Far As Possible"" - https://medicaldevicecourses.com/activity/p/19085/ Sat, 16 Nov 2019 19:37:24 -0500 Posted by: @fgk4 The ISO 14971:2012 “Risk management for medical devices” requires manufacturers to reduce risk As Far As Possible without any economical consideration. I consider this a huge Conundrum for all medical device manufacturers. It is a gray area…   Read more»

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