James,
I am aware of two products and I didn't like both of them. But I would take the freedom of offering some suggestions on how to shop around, if you are situated as such.
Please be familiar with the tracking requirements including FDA guidance at
http://wp.me/P4xpOK-18W Develop your SOP ADEQUATELY addressing all requirements.
Develop Software Requirement Specifications (SRSs) for your tracking software/system
Shop around device tracking softwares meeting "all your SRSs."
Validate and finalize the system on your own (e.g., your firm).
This way, you are taking both offensive and defensive approaches to survive any (negative) comments later by others in your firm.
Note: it is advised not to choose a product because someone (credible) recommends and says so."
____________________________________________________________ Dr. David Lim, Ph.D., RAC, ASQ-CQA "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor
Original Message:
Sent: 05-29-2015 09:18
From: James Wabby
Subject: Medical Device Tracking vendors
Hello,
Wondering if anyone could recommend supplier/vendors who can take on medical device tracking for various products?
Jim
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James Wabby
Director of Quality Systems and Risk Management
San Diego CA
United States
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