cubix rube
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We just completed our stage 2 for 13485, and were recommended for certification with 9 very minor non-conformances. I should start by saying that we are not a registered medical device OEM, but rather, a contract manufacturer that makes components for OEM customers. As such, any regulatory requirements not having been communicated to us by our customers, tend to go unnoticed here.
For example, our auditor pointed out that in our Q2 Management review, it was noted that "there are no new regulatory requirements that would affect our business." Our auditor mentioned some recent directive by the FDA pushing for the OEMs to exert more control over their contract manufacturers, and that this could very well affect our business. Now, the FDA may very well indeed notify the OEMs of such changes, but that rarely trickles down to us.
We are a very small company (25 employees), and do not have any sort of dedicated compliance officer, or anything like that.
Is there some sort of service to which we can subscribe, or something along those lines, that would notify us of any changes to regulatory requirements when they occur, so we're not left to just randomly pore through CFRs at some regular frequency looking for changes?
Any ideas would be greatly appreciated. Thanks!
For example, our auditor pointed out that in our Q2 Management review, it was noted that "there are no new regulatory requirements that would affect our business." Our auditor mentioned some recent directive by the FDA pushing for the OEMs to exert more control over their contract manufacturers, and that this could very well affect our business. Now, the FDA may very well indeed notify the OEMs of such changes, but that rarely trickles down to us.
We are a very small company (25 employees), and do not have any sort of dedicated compliance officer, or anything like that.
Is there some sort of service to which we can subscribe, or something along those lines, that would notify us of any changes to regulatory requirements when they occur, so we're not left to just randomly pore through CFRs at some regular frequency looking for changes?
Any ideas would be greatly appreciated. Thanks!