Discussion Categories

Category Name 655
Category Name
4 Topics 8 Posts

Category Description

Recent Topics

Relevance
Monica Deo
CAPA generation criteria for Medical Device
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 18d
Steven Schuelka
New Addition
2
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 20
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
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
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
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
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

Lisa Grosskopf
ISO 9001 Future Consideration
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
Lisa Grosskopf
Acceptability of FAI item with nonconformance?
1 19
From member Craig Koloske : Is it acceptable for an FAI to be completed on an item, even if there was a nonconformance ...
Lisa Grosskopf May '21
Veronique Boucher Veronique Boucher May '21
I would need more context from your situation to answer to it. Let's just say that if you had to rework your first ...

Forum Topic List

  • Topic
    Replies
    Views
    Last Post
Sort: