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George Marcel
Welcome to the Biomedical Division MyASQ - Please ...
8 78
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 16
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 ...
1 7
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!

Lisa Grosskopf
ASQ Medical Device LinkedIn Group
19
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
James Shore
Proactive Supplier Controls
28
ThI've posted e changes to ISO 13485:2016 have placed additional emphasis on Supplier Controls. As more ...
James Shore Nov '19
George Marcel
Change of name to the Division and Biomedical Auditor? ...
5 75
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
Christine Caruso
60601-1 General Standard plus particular standards
7
- the company I work for creates an x-ray component integrated into a larger medical device. 60601-2-44 applies to ...
Christine Caruso Apr '21
Maria Arciga-Morales
Combination Products
13 50
I am wondering if there are any forums on Combination Products. If not, would it be possible creating a Division on ...
Maria Arciga-Morales Jan '21
Lisa Grosskopf Lisa Grosskopf Jan '21
Hi Maria!

What a great question!  The Medical Device Division has many members that have worked with combination ...
Maria Arciga-Morales Maria Arciga-Morales Jan '21
Hi Lisa!

Thank you for replying to my post. Based on the description of the Healthcare Quality and Improvement ...
Lisa Grosskopf Lisa Grosskopf Jan '21
Hello again!

This may be the second reply--it appears my earlier message may have gotten lost.

I will reach out to ...
Lisa Grosskopf Lisa Grosskopf Feb '21
Hello Maria!

I have heard from the Chair of the FD&C Division. He said that some of his members are interested in ...
Maria Arciga-Morales Maria Arciga-Morales Feb '21
Hi Lisa,
Sorry for replying until now. I could not find the chain of this conversation. I am still interested on this ...
Lisa Grosskopf Lisa Grosskopf Feb '21
I think this is fabulous! Would you mind if I gave Tim Parrent (FD&C Chair) your contact info? We will set up a ...
Maria Arciga-Morales Maria Arciga-Morales Feb '21
Hi Lisa,
Of course, you may share my contact information. I also accepted the meeting invitation you sent me. I have ...
Tamira Sapp Tamira Sapp Feb '21
Hola Maria! Great question, and I volunteer as well! Happy new year!
Lisa Grosskopf Lisa Grosskopf Feb '21
Hi Tamira!

Sweet! We are scheduling our first planning meeting for next week. Would you be interested in ...
Maria Arciga-Morales Maria Arciga-Morales Feb '21
Hola Tamira! Welcome aboard! it will be great having you collaborating with us on this effort. Hope you can attend ...

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