M
Hello.
My company is manufacturing its first IVD device.
There is a long range of environmental specifications that the instrument is being evaluated against such as 15-30C, 20-80%RH, and 0-2000 m above sea level.
Is there any guidance as to the minimal amount of testing that these to be done for these types of requirements?
All comments are appreciated.
Best regards,
Mark
My company is manufacturing its first IVD device.
There is a long range of environmental specifications that the instrument is being evaluated against such as 15-30C, 20-80%RH, and 0-2000 m above sea level.
Is there any guidance as to the minimal amount of testing that these to be done for these types of requirements?
All comments are appreciated.
Best regards,
Mark