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. 


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
American Society of Quality November 3-4, 2022 Austin Texas The Line Hotel 111 E Cesar Chavez St Austin Texas 78701 Sample topics: FDA Adoption of ISO 13485 Virtual Auditing: Is it the future? Disaster Preparedness and Supply Chain Risk Combination Products: What’s new? Secure SDLC and IEC 62304 Cybersecurity Concerns for a Medical Device Latest ... more

Upcoming Events

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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
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
Ali Negahi Shirazi
Hello everyone,  I am Ali Negahi Shirazi, a Biomaterials Scientist and a CSSGB, and MBA candidate. Being new to ...
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 ...

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, ...
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
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:  ...
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
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 ...

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.