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George Marcel
Welcome to the Biomedical Division MyASQ - Please ...
8 81
Hello and welcome to the myASQ Biomedical Page... We are launching the new discussion forum and content resource ...
George Marcel May '19
Scott Moeller Scott Moeller May '19
This website is really going to help me stay connected to the Division activities! 

How can I help you? I am a Quality ...
Keith Councell Keith Councell May '19
Hello. Keith Councell here.

I am a Principle Quality Engineer for an over-the-counter oral care company in Grand ...
Edwin Bills Edwin Bills May '19
I am Edwin Bills, ASQ Fellow, thanks to many friends in the Biomedical Division.  Currently consulting and ...
Barrett Craner Barrett Craner May '19
I'm Barry Craner
Heavy interest and almost 20 years lecturing and teaching Risk Management, with so many thanks to ...
Dorian Pearson-Shaver Dorian Pearson-Shaver May '19
Hello. My name is Dorian Pearson-Shaver. I am a Quality Specialist for a medical device company in Orlando, FL. I am ...
Donna Campbell Donna Campbell Jun '19
Hello,
My name is Donna Campbell, I'm currently an assessor for BSI and a long time member of the Biomedical ...
Marcelo Favale Marcelo Favale Jun '19
Hello everyone.
I'm from Buenos Aires, Argentina.
I work as a QA manager in an IVD company. I've been working for 20 ...
Andrea Chamberlin Andrea Chamberlin Oct '19
My name is Andrea; I'm a second career Document Specialist working my way up to being a Quality Specialist.  

Right ...
Lisa Grosskopf
Acceptability of FAI item with nonconformance?
1 17
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 ...
Norm Howe
Looking for help with a De Novo medical device ...
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 Gordon Perry Jul '21

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

David Rothkopf David Rothkopf Apr '22

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

Lisa Grosskopf
ASQ Medical Device LinkedIn Group
22
Link to LinkedIn Group: Check out the new ASQ Medical Device Community Page! ...
Lisa Grosskopf Jan '21
Carolyn Wright
Medical Device Telemetry Usage
5
Hi everyone, I am reaching out to learn more about the use of telemetry for device performance or cyber threat ...
Carolyn Wright Sep '20
Alireza Khosh
Medical Device Sampling Plan justification
4 7
Hi Everyone, What are the requirements for Medical Device Sampling Plan justification? I am looking for a ...
Alireza Khosh 2d
Edwin Bills Edwin Bills 2d

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

David Manalan David Manalan 1d

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

Ajoy Basu Ajoy Basu 1d

Hi Alireza,

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

Edwin Bills Edwin Bills 1h
For Medical Devices FMEA Risk is not the same as ISO 14971 Risk. You should use Risk Analysis Risk and not FMEA Risk. ...
James Shore
Proactive Supplier Controls
29
ThI've posted e changes to ISO 13485:2016 have placed additional emphasis on Supplier Controls. As more ...
James Shore Nov '19
Norm Howe
Poka Yoke Awareness
4
NSF International is presenting a free webinar “Poka Yoke Awareness” on March 30, 9am EDT. How can you improve ...
Norm Howe Mar '22
George Marcel
Change of name to the Division and Biomedical Auditor? ...
5 76
Repost from Jim Shore - ASQ Biomedical LinkedIn Group - Please provide your input:   Change of name to the Division ...
George Marcel May '19
James Shore James Shore May '19
There has been some comments regarding combination devices and biomedical engineering.  I would suggest ...
Lisa Grosskopf Lisa Grosskopf Jun '19
Hi Jim,

Regarding " There has been some comments regarding combination devices and biomedical engineering.  I ...
Brijesh Patel Brijesh Patel Jun '19
I assume I was among the 10% that did not agree. It's sad but I would assume most voters were from Medical Device ...
Tami New Tami New Nov '19
I am not a big poster in this forum, but I am completely and passionately opposed to the name change.  Changing the ...
Lisa Grosskopf Lisa Grosskopf Nov '19
Thank you for posting.  I concur that changing the name would unintentionally narrow the focus of members and the ...
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

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