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 2023
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. 


New Medical Device Division Newsletter more
THIS WEDNESDAY 12/14/22 7PM - FREE IN PERSON EVENT >>>> NORTHERN CALIFORNIA DISCUSSION GROUP - MEDICAL DEVICE DIVISION of ASQ (Stellartech Research Corporation in Milpitas CA) TO REGISTER: GO TO EVENTBRITE https://dec2022ncdg. eventbrite.com ASQ Medical Device Division (formerly Biomedical Division) Northern California ... more
We're baaaaack! After a short hiatus the ASQ Medical Device Division DFW Discussion Group will resume our monthly webinars Wednesday October 26, at 7:00 P.M. CDT. DeLea Peichel will speak to us on Planning and Consideration in Setting up Clinical Trials . DeLea has over 25 years of experience designing, training and executing clinical studies for a ... more

Upcoming Events

Date & Time

Recent Discussions

Lisa Grosskopf
From member Craig Koloske : Is it ok to not secure Supplier Agreements with "off-the-shelf" suppliers?
Lisa Grosskopf May '21
Jose Dorbecker
Dear Members, I really appreaciate your comments on the following question: are the requirements from the Pharma ...
There is no requirement for annual product review per se, and no retention sample requirement unless it's part of ...
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
Monica Deo
Hello, We have recently started to take an in-depth look at our CAPA system. Our QMS currently states, “a CAPA may be ...
Monica Deo Sep '22

@Monica Deo
Hello Monica, I would also include risk.

If things are one off or infrequent and easily corrected, with ...

Ali Negahi Shirazi
Hello everyone,  I am Ali Negahi Shirazi, a Biomaterials Scientist and a CSSGB, and MBA candidate. Being new to ...
Norm Howe
Join us on June 21st, 8:00 pm ET / 5:00 pm Pacific, for ASQ Storytime, a fun story share where you are invited to share ...
Norm Howe Jun '22
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, ...
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
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:  ...
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 ...

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.