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Jeremiah Genest
FD&C Poster Share in Boston - Feburary 2023
1 2
The Food, Drug, and Cosmetic Division will be hosting a poster share on February 28th from 3-5 pm in Boston, with a ...
Jeremiah Genest 10d
Lisa Grosskopf Lisa Grosskopf 9d

@Jeremiah Genest
Thank you for sharing with the Medical Device Division! Best wishes with this event!

Monica Deo
Pharmaceutical GMP Professional vs. CMDA ...
1 6
Hi, I'm looking to get some insight and opinions into these two certifications. Is there one that is better to ...
Monica Deo Nov '22
Ajit Basrur Ajit Basrur Dec '22

@Monica Deo
I have both certifications. The BoK covers many aspects for both Pharma and Med Devices and is very ...

Monica Deo
CAPA generation criteria for Medical Device
1 7
Hello, We have recently started to take an in-depth look at our CAPA system. Our QMS currently states, “a CAPA may be ...
Monica Deo Sep '22
George Marcel George Marcel Oct '22

@Monica Deo
Hello Monica, I would also include risk.

If things are one off or infrequent and easily corrected, with ...

Steven Schuelka
New Addition
3
I am proud to announce: Hello Steven, Medical Division has been added to your Fellow Membership as per your ...
Steven Schuelka Jul '22
Alireza Khosh
Medical Device Sampling Plan justification
4 22
Hi Everyone, What are the requirements for Medical Device Sampling Plan justification? I am looking for a ...
Alireza Khosh Jun '22
Edwin Bills Edwin Bills Jun '22

Sampling plans must be statistically valid. The best way to do this is thru standards such as those available thru ...

David Manalan David Manalan Jun '22

I attach two articles addressing this topic. Even though it's old, Torbeck's article should be read before ...

Ajoy Basu Ajoy Basu Jun '22

Hi Alireza,

While there is no definitive guidance on sampling plans from the FDA, have used the following for ...

Edwin Bills Edwin Bills Jun '22
For Medical Devices FMEA Risk is not the same as ISO 14971 Risk. You should use Risk Analysis Risk and not FMEA Risk. ...
Norm Howe
Tell Us a Story
3
Join us on June 21st, 8:00 pm ET / 5:00 pm Pacific, for ASQ Storytime, a fun story share where you are invited to share ...
Norm Howe Jun '22
Shamantha Gunawardena
Vendor Qualification of Distributors
7
What are the sample survey questions you'd ask if your supplier is a distributor as opposed to manufacturers? Any ...
Shamantha Gunawardena Mar '22
Norm Howe
Poka Yoke Awareness
7
NSF International is presenting a free webinar “Poka Yoke Awareness” on March 30, 9am EDT. How can you improve ...
Norm Howe Mar '22
Timothy McShane
Looking for help on ISO standards
12
Hello All, I am pursuing a Quality and Regulatory Specialist position in a medical device company and I need to ...
Timothy McShane Nov '21
Rana Yanis
Artificial Intelligence Applications or medical ...
1 8
Greetings, I am looking into hospitals experience with AI for medical devices. Anyone who can share which ...
Rana Yanis Oct '21
Isabel Allen Isabel Allen Oct '21

Here is a list of all FDA approved algorithms and devices - might help identify use in hospitals

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