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 
As we initiate this site, please check the events - discussion groups (see event list below - registrationis via Eventbrite links) and national programs as announced, our discussion board and files list for relevant content. 

We will be sharing past program materials and continuing discussion on the range of pertinent medical device quality topics.

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. 

Upcoming Events

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Recent Discussions

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Carolyn Wright
Medical Device Telemetry Usage
4
Hi everyone, I am reaching out to learn more about the use of telemetry for device performance or cyber threat ...
Carolyn Wright 2d
John Thomas
Certified Validation Engineer?
1 13
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 21d
JT - I agree with you regarding having a Validation certification. I think it would be great to have one, and ...
Omri Arielly
Clean Room validation
1 15
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 Jeremiah Genest Apr '20
Start with ISO 14644

At a high level, Environmental Qualification for clean rooms in a GMP facility consist of the ...
    James Shore
    Proactive Supplier Controls
    21
    ThI've posted e changes to ISO 13485:2016 have placed additional emphasis on Supplier Controls. As more ...
    James Shore Nov '19
    George Marcel
    Reference Information fact sheet: ANSI / ISO - Common ...
    1 21
    See attached common acronyms for common ANSI / ISO references.
    George Marcel Oct '19
    Keith Councell Keith Councell Dec '19
    I love that fact that the document creates its own acronym (CUA) instead of just being called "Commonly Used ...
    George Marcel
    Call for Biomedical Division Participation - myASQ ...
    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
    George Marcel
    Change of name to the Division and Biomedical Auditor? ...
    5 67
    Repost from Jim Shore - ASQ Biomedical LinkedIn Group - Please provide your input:

     

    Change of name to the Division ...

      George Marcel May '19
      James Shore James Shore May '19
      There has been some comments regarding combination devices and biomedical engineering.  I would suggest ...
      Lisa Grosskopf Lisa Grosskopf Jun '19
      Hi Jim,

      Regarding " There has been some comments regarding combination devices and biomedical engineering.  I ...
      Brijesh Patel 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 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 ...
      Lisa Grosskopf Lisa Grosskopf Nov '19
      Thank you for posting.  I concur that changing the name would unintentionally narrow the focus of members and the ...
      George Marcel
      Welcome to the Biomedical Division MyASQ - Please ...
      8 64
      Hello and welcome to the myASQ Biomedical Page...

      We are launching the new discussion forum and content resource ...
      George Marcel May '19
      Scott Moeller 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 ...
      Keith Councell Keith Councell May '19
      Hello. Keith Councell here.

      I am a Principle Quality Engineer for an over-the-counter oral care company in Grand ...
      Edwin Bills Edwin Bills May '19
      I am Edwin Bills, ASQ Fellow, thanks to many friends in the Biomedical Division.  Currently consulting and ...
      Barrett Craner Barrett Craner May '19
      I'm Barry Craner
      Heavy interest and almost 20 years lecturing and teaching Risk Management, with so many thanks to ...
      Dorian Pearson-Shaver 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 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 ...
      Marcelo Favale 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 ...
      Andrea Chamberlin 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 ...

      Latest Resources

      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:
      1463

      Community Admins