Community Summit Europe | March 9-12, 2020 | Barcelona, Spain Register today
Hi AX Community!
Our business is running AX 2012 RTM. We are mainly a distributor for our parent company in Japan. Some of the products we plan to sell in the upcoming years will be regulated as medical devices by the FDA. This is uncharted territory for our business.
The products we are buying and selling that will be controlled by the FDA are mainly purchased from Japan, but there are some cables, computers, and other ancillary items that go with these devices that are ordered domestically that need to be collected into a 'kit' using a BOM from a production order. Then the 'kit' needs to be delivered and installed at the customer site.
We recognize that part of the requirements for the FDA will include segregation of our medical FDA products from our non-FDA medical products in our system to reduce the scope of inspection by the FDA.
I would like to discuss with an end-user of AX their experiences when going through this, and how they use their system to meet the requirements of the FDA. Look forward to any responses here. Thanks!
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