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2
- the company I work for creates an x-ray component integrated into a larger medical device. 60601-2-44 applies to ...
4
We're looking for someone with De Novo submission experience. If you're interested please contact me.
Norm Howe
Mar '21
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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 ...
13
In the summer, the ASQ Biomedical Division was re-named to the ASQ Medical Device Division. This change is ...
Lisa Grosskopf
Jan '21
2
27
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
27
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, ...
12
Link to LinkedIn Group: Check out the new ASQ Medical Device Community Page! ...
Lisa Grosskopf
Jan '21
10
Hello everyone, I am Ali Negahi Shirazi, a Biomaterials Scientist and a CSSGB, and MBA candidate. Being new to ...
Ali Negahi Shirazi
Nov '20
5
I’m working on project to set the shelf life of a medical vice. Previous studies have shown no failures, so I’ve ...
Dan O'Leary
Oct '20
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
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