Hi Anon: Even though 13485 does not require especially an approved supplier list you need to demonstrate that you purchase, components, parts, services advice etc that has an impact on the product read more
A letter of authorization from Merck would not be required unless you want to rely on information owned by Merck that was not reviewed as part of a marketing authorization application. ------------------------------ read more
As is kind of indirectly hinted in these replies, the end-of-life and disposal of the device needs to be considered in your risk management process and documented in your Risk Management File. ISO 14971:2019 read more
Hi Kimberly, That's a very good question. Each regulatory agency is different in how long they take to terminate recalls, with some doing so within days (New Zealand comes to mind), while others, as read more
Hello Anon Your required validation exercise isn't testing that SAP's software actually works. What you're checking is that your configuration does what you need it to do. (It's not that we never find read more
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Hi Everyone: Today's meeting is canceled on 5/3 at 3 pm. We had 3 people presenting case studies and 2 out of the 3 are sick. We will regroup next week with the case studies. Any questions feel free to email me at kunderwood@som.umaryland.edu. Have ...
I am the only RA person at an API manufacturer and found previous person in role set up a system of "commitments" where they tracked all documents shared with clients that may be used in regulatory filings. There is a change notification process in place ...
Hello RAPS Colorado Chapter, Colorado Bioscience Association has their 2024 Regulatory Symposium coming up on May 15th and we wanted to share with our Colorado Chapter members. "Regulatory Symposium: New Horizons in Data, AI, and Cyber Strategies ...
This message was posted by a user wishing to remain anonymous Hello, We are trying to file DMF via Medsafe in NZ. Medsafe requires EFT system to file the DMF. Has anyone faced any issues activating EFT system from Medsafe especially when all the information ...
This message was posted by a user wishing to remain anonymous I would appreciate it if anyone who has experience with Alcohol interaction studies could provide further guidance to my question. One approach to this study would be to use an ...
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