Welcome to the Medical Device Division!

2022 Conference Nov 3 & 4 - in person!

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. 


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
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

Upcoming Events

Date & Time
01/09/2023 2:30pm CST
860 Winter Street
Waltham, MA 02451
United States

Recent Discussions

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 ...
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 ...
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
Monica Deo
Hi, I'm looking to get some insight and opinions into these two certifications. Is there one that is better to ...
Alireza Khosh
Hi Everyone, What are the requirements for Medical Device Sampling Plan justification? I am looking for a ...
Alireza Khosh Jun '22

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 ...

Ajoy Basu Ajoy Basu Jun '22

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. ...
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
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

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.