Hi Elsmar
I have a question related to a specific issue regarding cleaning during use of an electronic transmitter.
My company has a system where an electronic transmitter is places in the users pocket or bag. The lifetime is expected to be two years. The IFU suggest the user to clean the transmitter daily and 3 different cleaning agents are recommended.
Now comes the question - should you verify this by simulating cleaning 730 (two years) times? If we need to follow our normal DV sampling plan, this testing job will be huge.
But, is it required? The risk management doesn't identify any risk beside that the transmitter could be broken and this doesn't introduce any risk for the user. Not performing the cleaning will neither introduce any risks.
Looking forward to get your inputs on this..
I have a question related to a specific issue regarding cleaning during use of an electronic transmitter.
My company has a system where an electronic transmitter is places in the users pocket or bag. The lifetime is expected to be two years. The IFU suggest the user to clean the transmitter daily and 3 different cleaning agents are recommended.
Now comes the question - should you verify this by simulating cleaning 730 (two years) times? If we need to follow our normal DV sampling plan, this testing job will be huge.
But, is it required? The risk management doesn't identify any risk beside that the transmitter could be broken and this doesn't introduce any risk for the user. Not performing the cleaning will neither introduce any risks.
Looking forward to get your inputs on this..