Lukas,
It is quite important to understand the storage and transport conditions through the entire life cycle of the device. We have noticed more Notified Bodies and other regulatory agencies wanting to see objective evidence of how the storage conditions are maintained through the storage, transport, and delivery to the customer. Depending on your device type or small window of storage conditions, you should use a risk based approach to determine whether you need temperature and/or humidity monitoring through the storage and transport. You may need contracts specifying temperature conditions during storage and transport, but this again will depend on the device type, risk, and conditions. Yes, it is a common question asked through the handling of the product to the customer so you should be prepared to defend as needed.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 02-Dec-2019 07:33
From: Lukas Peter
Subject: delivery contract ISO 13485
Dears,
I would like to ask, the delivery company is a subcontractor for the manufacturer of medical devices. Under ISO 13485 there should be some contract to specify that the service of the delivery will be provided in some conditions. On the device is pictogram humidity and temperature, should the company ask for some temperature curve, data during the delivery, should this information be in the contract? In which cases is it necessary?
Thank you very much
Best Regards
Lukas Peter
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Lukas Peter, Ph.D.
VSB-Technical University of Ostrava
Ostrava
Czech Republic
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