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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 ...
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
Norm Howe
We're looking for someone with De Novo submission experience. If you're interested please contact me.
Norm Howe Mar '21

Please consider posting at https://careers.asq.org/jobs. Thanks!

Hi Norm, you may want to talk to Scott Blood at www.medicept.com

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

Lisa Grosskopf
TC176 SC2 just published the Public Report on the Results of the ISO 9001 User Survey. This will be part of the input ...
Lisa Grosskopf Jun '21

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