Yeah, that helps. In writing our procedure, what I did is encompassed all requirements of Part 806 and Part 7 in the section outlining what is...
I am updating our Procedure on device removals, and in reading 21CFR7 Enforcement Policy and 21CFR806 Medical Devices; Reports of Corrections and...
Also, I just found this company with training options: Center for Professional Innovation and Education...
Just checking in to see if anyone has suggestions... Anyone used Oriel Stat A Matrix for training? It's one I came across during my online...
Can you specify what ones you recommend?
I agree that bringing in a consultant to address the problems head on and learn from them at the same time would be the most solid and timely...
Hi, My company has an ISO 13485 certified QMS - we manufacture IVD Medical Devices. I am looking to outsource training in the areas of risk...
No worries! thank you!
We use QT9 Quality Management software for ISO 13485. It has modules for all aspects of ISO 13485 compliance (all sold as one package, not...
Yes! That would be wonderful! I need to present a timeline for updating our system for CMDCAS, so any info on the changes needed is helpful. I...
Hi all, Does anyone have a summary or comparison of ISO 13485 and what is required by the CMDCAS addition? My company is looking into licensing...
Thank you all for the helpful input. Since we make in vitro diagnostics, with minimal risk to users, and the longest shelf life is 2 years, I...
Just trying to save on time to do this with historical records. We now scan them all in, but for the past 5 years we didn't. And I still need to...
Even the non-product related records such as corrective action reports, internal audits, etc.? These are not related directly to a batch or lot...
Hello, I am looking for some industry standard guidance on retention time for ISO 13485 certified systems. We manufacture single use IVDDs for...
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