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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!

Hi Norm, you may want to talk to Scott Blood at www.medicept.com

Shamantha Gunawardena
What are the sample survey questions you'd ask if your supplier is a distributor as opposed to manufacturers? Any ...
Norm Howe
NSF International is presenting a free webinar “Poka Yoke Awareness” on March 30, 9am EDT. How can you improve ...
Norm Howe Mar '22
Timothy McShane
Hello All, I am pursuing a Quality and Regulatory Specialist position in a medical device company and I need to ...
Timothy McShane Nov '21
Rana Yanis
Greetings, I am looking into hospitals experience with AI for medical devices. Anyone who can share which ...
Rana Yanis Oct '21

Here is a list of all FDA approved algorithms and devices - might help identify use in hospitals

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 ...

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