R
redknight07
Greetings guys,
I have been working on shipping stability study protocol for class III IVD (HIV Rapid Test Device). Could you help me with the existing standards that exist which determine what testing needs to be performed to evaluate the tolerance of product to unanticipated shipping conditions? Thank you.
I am using " Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of IVD Medical Devices (STED) Study Group 1 Final Document GHTF/SG1/SG1/N063:2011" as a reference document and this states that Shipping studies can be done under real and/or stimulated conditions and should include variable shipping conditions such as extreme heat/cold.
Can such a study be performed in house?
I am assuming that there is a standards which would be dealing with what needs to be covered in such a study. Can anybody shed some light on this? Thank you.
Best,
Aniket
I have been working on shipping stability study protocol for class III IVD (HIV Rapid Test Device). Could you help me with the existing standards that exist which determine what testing needs to be performed to evaluate the tolerance of product to unanticipated shipping conditions? Thank you.
I am using " Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of IVD Medical Devices (STED) Study Group 1 Final Document GHTF/SG1/SG1/N063:2011" as a reference document and this states that Shipping studies can be done under real and/or stimulated conditions and should include variable shipping conditions such as extreme heat/cold.
Can such a study be performed in house?
I am assuming that there is a standards which would be dealing with what needs to be covered in such a study. Can anybody shed some light on this? Thank you.
Best,
Aniket