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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
Jul '21
Please consider posting at https://careers.asq.org/jobs. Thanks!
3
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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13
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
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 ...
5
From member Craig Koloske : Is it ok to not secure Supplier Agreements with "off-the-shelf" suppliers?
Lisa Grosskopf
May '21
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
13
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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
Jan '21
Maria Arciga-Morales
Jan '21
Hi Lisa!
Thank you for replying to my post. Based on the description of the Healthcare Quality and Improvement ...
Thank you for replying to my post. Based on the description of the Healthcare Quality and Improvement ...
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 ...
This may be the second reply--it appears my earlier message may have gotten lost.
I will reach out to ...
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 ...
I have heard from the Chair of the FD&C Division. He said that some of his members are interested in ...
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 ...
Sorry for replying until now. I could not find the chain of this conversation. I am still interested on this ...
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
Feb '21
Hi Lisa,
Of course, you may share my contact information. I also accepted the meeting invitation you sent me. I have ...
Of course, you may share my contact information. I also accepted the meeting invitation you sent me. I have ...
Tamira Sapp
Feb '21
Hola Maria! Great question, and I volunteer as well! Happy new year!
Lisa Grosskopf
Feb '21
Hi Tamira!
Sweet! We are scheduling our first planning meeting for next week. Would you be interested in ...
Sweet! We are scheduling our first planning meeting for next week. Would you be interested in ...
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 ...
14
In the summer, the ASQ Biomedical Division was re-named to the ASQ Medical Device Division. This change is ...
Lisa Grosskopf
Jan '21
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28
See attached common acronyms for common ANSI / ISO references.
George Marcel
Oct '19
Keith Councell
Dec '19
I love that fact that the document creates its own acronym (CUA) instead of just being called "Commonly Used ...
Ajit Basrur
Jan '21
See here: ...
3
29
Why doesn't ASQ have a Validation certification? I think it would be valuable to the members of this division. ...
John Thomas
Apr '20
Tami New
Sep '20
JT - I agree with you regarding having a Validation certification. I think it would be great to have one, and ...
Lisa Grosskopf
Nov '20
I like this! A validation certificate would be beneficial. A couple of us on the Leadership Team have discussed ...
Ajit Basrur
Jan '21
Absolutely - the "Validation" could be an overarching concept to include Equipment, Process, Software, ...
15
Link to LinkedIn Group: Check out the new ASQ Medical Device Community Page! ...
Lisa Grosskopf
Jan '21
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