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Norm Howe
We're looking for someone with De Novo submission experience. If you're interested please contact me.
Norm Howe Mar '21

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

Lisa Grosskopf
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
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
I would need more context from your situation to answer to it. Let's just say that if you had to rework your first ...
Lisa Grosskopf
From member Craig Koloske : Is it ok to not secure Supplier Agreements with "off-the-shelf" suppliers?
Lisa Grosskopf May '21
Christine Caruso
- the company I work for creates an x-ray component integrated into a larger medical device. 60601-2-44 applies to ...
Maria Arciga-Morales
I am wondering if there are any forums on Combination Products. If not, would it be possible creating a Division on ...
Hi Maria!

What a great question!  The Medical Device Division has many members that have worked with combination ...
Hi Lisa!

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

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

I will reach out to ...
Hello Maria!

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

Sweet! We are scheduling our first planning meeting for next week. Would you be interested in ...
Hola Tamira! Welcome aboard! it will be great having you collaborating with us on this effort. Hope you can attend ...
Lisa Grosskopf
In the summer, the ASQ Biomedical Division was re-named to the ASQ Medical Device Division. This change is ...
Lisa Grosskopf Jan '21
George Marcel
See attached common acronyms for common ANSI / ISO references.
George Marcel Oct '19
I love that fact that the document creates its own acronym (CUA) instead of just being called "Commonly Used ...
See here:  ...
John Thomas
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 Tami New Sep '20
JT - I agree with you regarding having a Validation certification. I think it would be great to have one, and ...
I like this!  A validation certificate would be beneficial.  A couple of us on the Leadership Team have discussed ...
Absolutely - the "Validation" could be an overarching concept to include Equipment, Process, Software, ...
Lisa Grosskopf
Link to LinkedIn Group: Check out the new ASQ Medical Device Community Page! ...
Lisa Grosskopf Jan '21

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