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

Monica Deo
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

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

Monica Deo
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

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

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

Steven Schuelka
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
Hi Everyone, What are the requirements for Medical Device Sampling Plan justification? I am looking for a ...
Alireza Khosh Jun '22

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

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 ...

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
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
What are the sample survey questions you'd ask if your supplier is a distributor as opposed to manufacturers? Any ...
Norm Howe
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
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
Greetings, I am looking into hospitals experience with AI for medical devices. Anyone who can share which ...
Rana Yanis Oct '21

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

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