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12
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!
David Rothkopf
23d
Hi Norm, you may want to talk to Scott Blood at www.medicept.com
4
What are the sample survey questions you'd ask if your supplier is a distributor as opposed to manufacturers? Any ...
Shamantha Gunawardena
Mar '22
2
NSF International is presenting a free webinar “Poka Yoke Awareness” on March 30, 9am EDT. How can you improve ...
Norm Howe
Mar '22
3
Hello All, I am pursuing a Quality and Regulatory Specialist position in a medical device company and I need to ...
Timothy McShane
Nov '21
1
8
Greetings, I am looking into hospitals experience with AI for medical devices. Anyone who can share which ...
Rana Yanis
Oct '21
Isabel Allen
Oct '21
Here is a list of all FDA approved algorithms and devices - might help identify use in hospitals
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
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
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
8
- 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 ...
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