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
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
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
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 ...
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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 ...
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Upcoming Events
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Recent Discussions
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11
From member Craig Koloske : Is it ok to not secure Supplier Agreements with "off-the-shelf" suppliers?
Lisa Grosskopf
May '21
1
8
Dear Members, I really appreaciate your comments on the following question: are the requirements from the Pharma ...
Jose Dorbecker
24d
David Manalan
24d
There is no requirement for annual product review per se, and no retention sample requirement unless it's part of ...
15
In the summer, the ASQ Biomedical Division was re-named to the ASQ Medical Device Division. This change is ...
Lisa Grosskopf
Jan '21
1
12
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
George Marcel
Oct '22
@Monica Deo
Hello Monica, I would also include risk.
If things are one off or infrequent and easily corrected, with ...
14
Hello everyone, I am Ali Negahi Shirazi, a Biomaterials Scientist and a CSSGB, and MBA candidate. Being new to ...
Ali Negahi Shirazi
Nov '20
3
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
3
32
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
Sep '20
JT - I agree with you regarding having a Validation certification. I think it would be great to have one, and ...
Lisa Grosskopf
Nov '20
I like this! A validation certificate would be beneficial. A couple of us on the Leadership Team have discussed ...
Ajit Basrur
Jan '21
Absolutely - the "Validation" could be an overarching concept to include Equipment, Process, Software, ...
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
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: ...
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 ...
Latest Resources
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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 -
MDD Award Information
Nothing entered.
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:
3477
Community Admins
