Welcome

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 2021
Geographical Discussion Groups

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. 

News

Slides and a recording of the July 14, 2021 Dallas/Fort Worth Discussion Group webinar Simple, Quick, Practical Alternative to Performing Gage R&R and Specification Guardbanding presented by John Zorich are available under the Files tab on the MyASQ Medical Device Division Community page. They can be accessed by clinking the link below. ... more
Dear segment leaders with manufacturing oriented members; Thanks for announcing the Leading Indicators research and survey webinar this evening to your membership. We have had a request for a second presentation of the topic on April 6 th . Please share this announcement with your membership. We are hoping to get a critical mass of survey volunteers ... more
Part I on Auditing contains new content on Data Privacy, Data Integrity Principles, and the Medical Device Single Audit Program (MDSAP). Part II on Medical Device Quality Management System Requirements contains an entirely new Chapter 6, as the subject of “The EU Medical Device Regulation” has replaced “The EU Medical Device Directives.” Chapters ... more

Upcoming Events

No Data Available

Recent Discussions

Relevance
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 ...
Hello,
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!

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
James Shore
ThI've posted e changes to ISO 13485:2016 have placed additional emphasis on Supplier Controls. As more ...
James Shore Nov '19
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
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 ...

Latest Resources

Community Information
Category:
Technical
Description:
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.
Access:
Public
Members:
2325