-
cem34 replied to the topic "how far is "As Far As Possible"" – 3 years, 5 months ago
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»
-
jailynp26 replied to the topic "how far is "As Far As Possible"" – 3 years, 6 months ago
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»
-
mejefferson replied to the topic "how far is "As Far As Possible"" – 3 years, 6 months ago
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»
-
rajamharrison replied to the topic "When is validation is not required?" – 3 years, 6 months ago
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»
-
arianaburch replied to the topic "When is validation is not required?" – 3 years, 6 months ago
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»
-
mejefferson replied to the topic "When is validation is not required?" – 3 years, 7 months ago
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»
-
JordanKayal replied to the topic "how far is "As Far As Possible"" – 5 years, 5 months ago
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»
