Welcome to the Medical Device Division!

Formerly the Biomedical Division, our website is dedicated to advancing medical device quality and compliance knowledge:
  • addressing new hot topics
  • providing  discussion forums
  • supporting medical device training competency 
  • building networks 
Medical Device Auditor Body of Knowledge
Committees 2021 Objective
BioFeedback - back issues
Webinar recordings
Medical Device Division Leadership Team 2022
Geographical Discussion Groups
Scholarships and Grants

If you would like to see something specific posted or discussed, please reach out to any of the Community Admins. 

Please invite your fellow ASQ members to become active members of our community. 


Please join the Dallas Fort Worth Medical Device Division Group June 8, 2022 7:00-8:00 P.M. CDT for our June webinar. Adding “Technical” back into Design Reviews: 3 Alternatives to Bulleted Slide Decks Presenter-Dianna Deeney Technical Design Reviews are important meetings to hold with our team and management to make decisions about what we’re ... more
WCQI 2022 Monday night *Medieval Times Dinner and Tournament* Event Date: Monday, May 16, 2022 | Event Time: 5:30 - 9:30 pm Event Location: Pick up in front of Anaheim Convention Center - bus transportation provided to Medieval Times in Buena Park WCQI Monday evening fun is back! Join the ASQ Medical Device Division for an evening of fun and comradery at ... more
On February 23, 2022 the U.S. Food and Drug Administration (FDA) published the proposed ruling of changes to the current 21 CFR part 820 – Quality System Regulation (QSR) and upon finalization, will be referred to as the ‘Quality Management System Regulation (QMSR).’ This ruling, among other changes, incorporates a significant shift incorporating ... more

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Recent Discussions

George Marcel
Hello and welcome to the myASQ Biomedical Page... We are launching the new discussion forum and content resource ...
George Marcel May '19
This website is really going to help me stay connected to the Division activities! 

How can I help you? I am a Quality ...
Hello. Keith Councell here.

I am a Principle Quality Engineer for an over-the-counter oral care company in Grand ...
I am Edwin Bills, ASQ Fellow, thanks to many friends in the Biomedical Division.  Currently consulting and ...
I'm Barry Craner
Heavy interest and almost 20 years lecturing and teaching Risk Management, with so many thanks to ...
Hello. My name is Dorian Pearson-Shaver. I am a Quality Specialist for a medical device company in Orlando, FL. I am ...
My name is Donna Campbell, I'm currently an assessor for BSI and a long time member of the Biomedical ...
Hello everyone.
I'm from Buenos Aires, Argentina.
I work as a QA manager in an IVD company. I've been working for 20 ...
My name is Andrea; I'm a second career Document Specialist working my way up to being a Quality Specialist.  

Right ...
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 ...
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

Lisa Grosskopf
Link to LinkedIn Group: Check out the new ASQ Medical Device Community Page! ...
Lisa Grosskopf Jan '21
Carolyn Wright
Hi everyone, I am reaching out to learn more about the use of telemetry for device performance or cyber threat ...
Carolyn Wright Sep '20
Alireza Khosh
Hi Everyone, What are the requirements for Medical Device Sampling Plan justification? I am looking for a ...

Sampling plans must be statistically valid. The best way to do this is thru standards such as those available thru ...

I attach two articles addressing this topic. Even though it's old, Torbeck's article should be read before ...

Hi Alireza,

While there is no definitive guidance on sampling plans from the FDA, have used the following for ...

For Medical Devices FMEA Risk is not the same as ISO 14971 Risk. You should use Risk Analysis Risk and not FMEA Risk. ...
James Shore
ThI've posted e changes to ISO 13485:2016 have placed additional emphasis on Supplier Controls. As more ...
James Shore Nov '19
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
George Marcel
Repost from Jim Shore - ASQ Biomedical LinkedIn Group - Please provide your input:   Change of name to the Division ...
George Marcel May '19
There has been some comments regarding combination devices and biomedical engineering.  I would suggest ...
Hi Jim,

Regarding " There has been some comments regarding combination devices and biomedical engineering.  I ...
I assume I was among the 10% that did not agree. It's sad but I would assume most voters were from Medical Device ...
Tami New Tami New Nov '19
I am not a big poster in this forum, but I am completely and passionately opposed to the name change.  Changing the ...
Thank you for posting.  I concur that changing the name would unintentionally narrow the focus of members and the ...
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

Latest Resources

Community Information
The ASQ Medical Device Division focuses on its awareness that Quality has a primary role in providing quality medical devices to patients and healthcare professionals. The ASQ Medical Device Division focuses on its awareness that Quality has a primary role in providing quality medical devices to patients and healthcare professionals.