Welcome
Welcome to the Medical Device Division!
Formerly the Biomedical Division, our website is dedicated to advancing medical device quality and compliance 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.
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
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.
News
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
Upcoming Events
Recent Discussions
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8
81
Hello and welcome to the myASQ Biomedical Page... We are launching the new discussion forum and content resource ...
George Marcel
May '19
Scott Moeller
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 ...
How can I help you? I am a Quality ...
Keith Councell
May '19
Hello. Keith Councell here.
I am a Principle Quality Engineer for an over-the-counter oral care company in Grand ...
I am a Principle Quality Engineer for an over-the-counter oral care company in Grand ...
Edwin Bills
May '19
I am Edwin Bills, ASQ Fellow, thanks to many friends in the Biomedical Division. Currently consulting and ...
Barrett Craner
May '19
I'm Barry Craner
Heavy interest and almost 20 years lecturing and teaching Risk Management, with so many thanks to ...
Heavy interest and almost 20 years lecturing and teaching Risk Management, with so many thanks to ...
Dorian Pearson-Shaver
May '19
Hello. My name is Dorian Pearson-Shaver. I am a Quality Specialist for a medical device company in Orlando, FL. I am ...
Donna Campbell
Jun '19
Hello,
My name is Donna Campbell, I'm currently an assessor for BSI and a long time member of the Biomedical ...
My name is Donna Campbell, I'm currently an assessor for BSI and a long time member of the Biomedical ...
Marcelo Favale
Jun '19
Hello everyone.
I'm from Buenos Aires, Argentina.
I work as a QA manager in an IVD company. I've been working for 20 ...
I'm from Buenos Aires, Argentina.
I work as a QA manager in an IVD company. I've been working for 20 ...
Andrea Chamberlin
Oct '19
My name is Andrea; I'm a second career Document Specialist working my way up to being a Quality Specialist.
Right ...
Right ...
1
17
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
Veronique Boucher
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 ...
2
13
We're looking for someone with De Novo submission experience. If you're interested please contact me.
Norm Howe
Mar '21
Gordon Perry
Jul '21
Please consider posting at https://careers.asq.org/jobs. Thanks!
David Rothkopf
Apr '22
Hi Norm, you may want to talk to Scott Blood at www.medicept.com
22
Link to LinkedIn Group: Check out the new ASQ Medical Device Community Page! ...
Lisa Grosskopf
Jan '21
5
Hi everyone, I am reaching out to learn more about the use of telemetry for device performance or cyber threat ...
Carolyn Wright
Sep '20
4
11
Hi Everyone, What are the requirements for Medical Device Sampling Plan justification? I am looking for a ...
Edwin Bills
7d
Sampling plans must be statistically valid. The best way to do this is thru standards such as those available thru ...
Ajoy Basu
6d
Hi Alireza,
While there is no definitive guidance on sampling plans from the FDA, have used the following for ...
Edwin Bills
5d
For Medical Devices FMEA Risk is not the same as ISO 14971 Risk. You should use Risk Analysis Risk and not FMEA Risk. ...
29
ThI've posted e changes to ISO 13485:2016 have placed additional emphasis on Supplier Controls. As more ...
James Shore
Nov '19
4
NSF International is presenting a free webinar “Poka Yoke Awareness” on March 30, 9am EDT. How can you improve ...
Norm Howe
Mar '22
5
76
Repost from Jim Shore - ASQ Biomedical LinkedIn Group - Please provide your input: Change of name to the Division ...
George Marcel
May '19
James Shore
May '19
Lisa Grosskopf
Jun '19
Hi Jim,
Regarding " There has been some comments regarding combination devices and biomedical engineering. I ...
Regarding " There has been some comments regarding combination devices and biomedical engineering. I ...
Brijesh Patel
Jun '19
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
Nov '19
Lisa Grosskopf
Nov '19
Thank you for posting. I concur that changing the name would unintentionally narrow the focus of members and the ...
4
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
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Division Leadership Team
Senior Leadership Team Chair Teresa Cherry Chair Elect Anesh Tilwani Treasurer Scott Moeller Secretary Bob Shanks Past Chair Lisa Grosskopf ASQ Segment Manager Katie Chitwood Scholarship and ...
Date Created: 10/05/2021 09:45 PM -
Discussion Groups
Geographical interest groups. Contact the Chair or see the LinkedIn page for information about the group.
New England Discussion Group, 2021 Chair, Scott Blood, New England Medical Device Discussion Group | Groups | LinkedIn
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Date Created: 02/12/2021 10:47 PM -
2020 CMDA BoK Map Final
Nothing entered.
Date Created: 01/18/2021 12:57 AM -
MDD Award Information
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Date Created: 10/28/2020 02:59 AM
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.
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Members:
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Community Admins
