Storage Managment (Stock Control and Storage) procedure for Medical Device

[Chua Kwan Teng]

Hi

Can anyone share with me storage management (Stock control and storage)procedure for medical device.

I need it as part of the implementation of ISO 13485 Std

Thanks in advance

KT Chua

 

[MIREGMGR]

Re: Storage managment procedure for medical device

What kind of device? Storage at what location...your shipping department, your distributor's warehouse, your end user's stockroom? What are the technical and managerial issues applicable to the product that cause a need for you to specify particular storage methods?

 

[Chua Kwan Teng]

Re: Storage managment procedure for medical device

The medical device I am referring is vitro diagnostic devices (class C) and these devices will be stored in the company warehouse before shipping to customer. We will like to have a storage control procedure that will comply us to ISO 13485: 2003 requirements.

Thanks and regards

KT Chua

 

[treesei]

Key issues:

1. Product identification. No mix-up etc.

2. If the product requires special storage environment, that is what you need to pay attention to. Understand, define, control, monitor this environment and keep records that show that the above have been successfully done.