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 2021
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 2021
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
Breaking IVDR/MDR News - today the European Commission published an information Notice to confirm that Notified Bodies may temporarily deviate, in extraordinary and individual cases, from the IVDR/MDR requirement for audits of manufacturers’ quality management systems (QMS) to take place ‘on site.’ This is a significant and positive ...
more
Hidden in the recently approved COVD funding bill is additional funding for FDA. The FDA received $55m on the battle against COVID 19 (including $1.5m to monitor medical supply chains and funding on reforms for OTC drugs). There is also an increase of $42m to fiscal FDA funding. Hidden in the $42m are some interesting line items, like $7m for artificial ...
more
Historical reference summary of the MDD Scholarship Program, formerly known as the Biomedical Division Scholarship Program, is summarized as follows; there were three (3) Scholarships, there were two (2) Awards, and one (1) Grant. The Scholarships were named after the following individuals: Barrett C. Craner, William J. Feingold, and Cliff ...
more
Upcoming Events
Recent Discussions
Relevance
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Link to LinkedIn Group: Check out the new ASQ Medical Device Community Page! ...
8
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
I’m working on project to set the shelf life of a medical vice. Previous studies have shown no failures, so I’ve ...
Dan O'Leary
Oct '20
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
3
19
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
4h
Absolutely - the "Validation" could be an overarching concept to include Equipment, Process, Software, ...
1
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Hey everyone, i hope i'm in the right forum, if not please forgive me. we are currently in the process of designing ...
Omri Arielly
Mar '20
Jeremiah Genest
Apr '20
Start with ISO 14644
At a high level, Environmental Qualification for clean rooms in a GMP facility consist of the ...
At a high level, Environmental Qualification for clean rooms in a GMP facility consist of the ...
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ThI've posted e changes to ISO 13485:2016 have placed additional emphasis on Supplier Controls. As more ...
James Shore
Nov '19
2
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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
4h
See here: ...
11
Hello Biomedical Division members, As of today 10/21/19, this group on myASQ has grown to 410 so far since launch ...
George Marcel
Oct '19
5
73
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 ...
Latest Resources
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2020 CMDA BoK Map Final
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Date Created: 01/17/2021 06:57 PM -
2021 Medical Device Leadership Team
Senior Leadership Team Chair Lisa Grosskopf Chair Elect Shreya Chandrasekhar Treasurer Anesh Tilwani Secretary Scott Moeller Past Chair Karen Brozowski ASQ Segment Manager Katie Chitwood
Date Created: 01/17/2021 06:48 PM -
MDD Award Information
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Date Created: 10/27/2020 09:59 PM -
Helpful device registration links
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Date Created: 10/27/2020 06:56 PM
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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