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3
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
24d
2
I am proud to announce: Hello Steven, Medical Division has been added to your Fellow Membership as per your ...
Steven Schuelka
Jul '22
4
20
Hi Everyone, What are the requirements for Medical Device Sampling Plan justification? I am looking for a ...
Alireza Khosh
Jun '22
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
Jun '22
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
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. ...
2
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
2
13
We're looking for someone with De Novo submission experience. If you're interested please contact me.
Norm Howe
Mar '21
Gordon Perry
Jul '21
Please consider posting at https://careers.asq.org/jobs. Thanks!
David Rothkopf
Apr '22
Hi Norm, you may want to talk to Scott Blood at www.medicept.com
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
7
NSF International is presenting a free webinar “Poka Yoke Awareness” on March 30, 9am EDT. How can you improve ...
Norm Howe
Mar '22
10
Hello All, I am pursuing a Quality and Regulatory Specialist position in a medical device company and I need to ...
Timothy McShane
Nov '21
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
Oct '21
Here is a list of all FDA approved algorithms and devices - might help identify use in hospitals
4
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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