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 2023
Geographical Discussion Groups
Scholarships and Grants - Academic scholarship deadline extended to May 31!
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 2023
Geographical Discussion Groups
Scholarships and Grants - Academic scholarship deadline extended to May 31!
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
Minneapolis, Minnesota Call for Sponsors - October 10-11, 2023 The ASQ Minnesota Section and ASQ Medical Device Division are seeking sponsors for our in person conference to be held in conjunction with the Informa MD&M Meeting in Minneapolis. This year’s conference theme is: Old Problems, New Solutions! This is a fantastic opportunity to ...
more
Congratulations to the 2022 Awardees for Member Unit Performance Excellence! Published The Performance Excellence Program (PEP) Committee is happy to announce the 2022 recipients of Gold, Silver, and Bronze recognition! Measures included in the 2022 award program were: Contributions to ASQ thought leadership, as measured by myASQ content ...
more
https://www.eventbrite.com/e/asq-certified-medical-device-auditor-cmda-refresher-course-tickets-331556714057
more
Upcoming Events
Recent Discussions
Relevance
2
32
See attached common acronyms for common ANSI / ISO references.
George Marcel
Oct '19
Keith Councell
Dec '19
I love that fact that the document creates its own acronym (CUA) instead of just being called "Commonly Used ...
Ajit Basrur
Jan '21
See here: ...
14
Hello All, I am pursuing a Quality and Regulatory Specialist position in a medical device company and I need to ...
Timothy McShane
Nov '21
8
82
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
19
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 ...
3
9
Hi Everyone, I am planning to take CMDA training but since ASQ is not offering any online course currently, I am ...
Teresita Lourdes Repaso
Mar '23
Laura Menck
Mar '23
@Teresita Lourdes Repaso I cannot speak to this training but I did just pass the CMDA and I used the primer and ...
Teresita Lourdes Repaso
Mar '23
@Laura Menck Thank you very much. How long did it take for you to complete the exam prep? You mentioned you used the ...
Laura Menck
Mar '23
@Teresita Lourdes Repaso I also used the ASQ Handbook and had both at the exam. I studied over a period of about four ...
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
1
10
Hi, I'm looking to get some insight and opinions into these two certifications. Is there one that is better to ...
Monica Deo
Nov '22
Ajit Basrur
Dec '22
@Monica Deo
I have both certifications. The BoK covers many aspects for both Pharma and Med Devices and is very ...
26
Link to LinkedIn Group: Check out the new ASQ Medical Device Community Page! ...
Lisa Grosskopf
Jan '21
4
32
Hi Everyone, What are the requirements for Medical Device Sampling Plan justification? I am looking for a ...
Alireza Khosh
Jun '22
Edwin Bills
Jun '22
Sampling plans must be statistically valid. The best way to do this is thru standards such as those available thru ...
David Manalan
Jun '22
Ajoy Basu
Jun '22
Hi Alireza,
While there is no definitive guidance on sampling plans from the FDA, have used the following for ...
Edwin Bills
Jun '22
For Medical Devices FMEA Risk is not the same as ISO 14971 Risk. You should use Risk Analysis Risk and not FMEA Risk. ...
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
Latest Resources
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RICHARD J. SCHLESINGER GRANT
The Vision of the Medical Device Division of ASQ is to make quality control and assurance in biomedical products and systems as a global priority, an organizational imperative, and a personal ethic. The ASQ Medical Device Division ...
Date Created: 04/19/2023 04:13 AM -
Division Leadership Team
Senior Leadership Team Chair Anesh Tilwani Chair Elect Scott Moeller Treasurer Bob Shanks Secretary Mark Swanson Past Chair Teresa Cherry 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, 2023 Chair, Dennis Shay
New England Medical Device Discussion Group | Groups | LinkedIn
...
Date Created: 02/12/2021 10:47 PM -
2020 CMDA BoK Map Final
Nothing entered.
Date Created: 01/18/2021 12:57 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.
Access:
Public
Members:
3534
Community Admins
