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

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Historical reference summary of the MDD Scholarship Program, formerly known as the Biomedical Division Scholarship Program, is summarized as follows; there were three (3)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

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Recent Discussions

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Lisa Grosskopf
Link to LinkedIn Group: Check out the new ASQ Medical Device Community Page! ...
Ali Negahi Shirazi
Hello everyone,  I am Ali Negahi Shirazi, a Biomaterials Scientist and a CSSGB, and MBA candidate. Being new to ...
Dan O'Leary
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
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
John Thomas
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 Tami New Sep '20
JT - I agree with you regarding having a Validation certification. I think it would be great to have one, and ...
I like this!  A validation certificate would be beneficial.  A couple of us on the Leadership Team have discussed ...
Absolutely - the "Validation" could be an overarching concept to include Equipment, Process, Software, ...
Omri Arielly
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
Start with ISO 14644

At a high level, Environmental Qualification for clean rooms in a GMP facility consist of the ...
    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
    See attached common acronyms for common ANSI / ISO references.
    George Marcel Oct '19
    I love that fact that the document creates its own acronym (CUA) instead of just being called "Commonly Used ...
    See here:  ...
    George Marcel
    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
    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 ...

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    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:
    1772