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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
Geographical Discussion Groups

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

Upcoming Events

The Silicon Valley ASQ Section will host a Zoom presentation by Ms. Christina Zhou, CBA, CQE, and RAC, entitled “Challenges and Improvements of Global Regulatory Submission”. Link to event info. The ASQ Medical Device Division DFW and Northern California Discussion Groups present part one of a three part series on Software Quality Assurance "Game ... more

Posted by Lisa Grosskopf on Medical Device Division (Formerly Biomedical Division) Aug 17, 2021 7:54 PM CDT

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Simple, Quick, Practical Alternative To Performing Gage R&R And Specification Guardbanding

Slides and a recording of the July 14, 2021 Dallas/Fort Worth Discussion Group webinar Simple, Quick, Practical Alternative to Performing Gage R&R and Specification Guardbanding presented by John Zorich are available under the Files tab on the MyASQ Medical Device Division Community page. They can be accessed by clinking the link below. ... more

Posted by Lisa Grosskopf on Medical Device Division (Formerly Biomedical Division) Jul 20, 2021 9:09 PM CDT

Announcement Of Second Webinar On Leading Indicators Research For Cost Of Quality And Survey

Dear segment leaders with manufacturing oriented members; Thanks for announcing the Leading Indicators research and survey webinar this evening to your membership. We have had a request for a second presentation of the topic on April 6 th . Please share this announcement with your membership. We are hoping to get a critical mass of survey volunteers ... more

Posted by Lisa Grosskopf on Medical Device Division (Formerly Biomedical Division) Mar 19, 2021 9:03 AM CDT

Upcoming Events

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Recent Discussions

Acceptability of FAI item with nonconformance?

1 12

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

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 ...

Welcome to the Biomedical Division MyASQ - Please ...

8 73

Hello and welcome to the myASQ Biomedical Page... We are launching the new discussion forum and content resource ...

George Marcel May '19

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 ...

May '19

Hello. Keith Councell here.

I am a Principle Quality Engineer for an over-the-counter oral care company in Grand ...

May '19

I am Edwin Bills, ASQ Fellow, thanks to many friends in the Biomedical Division. Currently consulting and ...

May '19

I'm Barry Craner
Heavy interest and almost 20 years lecturing and teaching Risk Management, with so many thanks to ...

May '19

Hello. My name is Dorian Pearson-Shaver. I am a Quality Specialist for a medical device company in Orlando, FL. I am ...

Jun '19

Hello,
My name is Donna Campbell, I'm currently an assessor for BSI and a long time member of the Biomedical ...

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 ...

Oct '19

My name is Andrea; I'm a second career Document Specialist working my way up to being a Quality Specialist.

Right ...

Looking for help with a De Novo medical device ...

1 7

We're looking for someone with De Novo submission experience. If you're interested please contact me.

Norm Howe Mar '21

Jul '21

Please consider posting at https://careers.asq.org/jobs. Thanks!

ASQ Medical Device LinkedIn Group

Link to LinkedIn Group: Check out the new ASQ Medical Device Community Page! ...

Lisa Grosskopf Jan '21

Medical Device Telemetry Usage

Hi everyone, I am reaching out to learn more about the use of telemetry for device performance or cyber threat ...

Carolyn Wright Sep '20

Proactive Supplier Controls

ThI've posted e changes to ISO 13485:2016 have placed additional emphasis on Supplier Controls. As more ...

James Shore Nov '19

ISO 9001 Future Consideration

TC176 SC2 just published the Public Report on the Results of the ISO 9001 User Survey. This will be part of the input ...

Lisa Grosskopf Jun '21

Change of name to the Division and Biomedical Auditor? ...

5 75

Repost from Jim Shore - ASQ Biomedical LinkedIn Group - Please provide your input: Change of name to the Division ...

George Marcel May '19

May '19

There has been some comments regarding combination devices and biomedical engineering. I would suggest ...

Jun '19

Hi Jim,

Regarding " There has been some comments regarding combination devices and biomedical engineering. I ...

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 ...

Nov '19

I am not a big poster in this forum, but I am completely and passionately opposed to the name change. Changing the ...

Nov '19

Thank you for posting. I concur that changing the name would unintentionally narrow the focus of members and the ...

60601-1 General Standard plus particular standards

- the company I work for creates an x-ray component integrated into a larger medical device. 60601-2-44 applies to ...

Christine Caruso Apr '21

Combination Products

13 50

I am wondering if there are any forums on Combination Products. If not, would it be possible creating a Division on ...

Maria Arciga-Morales Jan '21

Jan '21

Hi Maria!

What a great question! The Medical Device Division has many members that have worked with combination ...

Jan '21

Hi Lisa!

Thank you for replying to my post. Based on the description of the Healthcare Quality and Improvement ...

Jan '21

Hello again!

This may be the second reply--it appears my earlier message may have gotten lost.

I will reach out to ...

Feb '21

Hello Maria!

I have heard from the Chair of the FD&C Division. He said that some of his members are interested in ...

Feb '21

Hi Lisa,
Sorry for replying until now. I could not find the chain of this conversation. I am still interested on this ...

Feb '21

I think this is fabulous! Would you mind if I gave Tim Parrent (FD&C Chair) your contact info? We will set up a ...

Feb '21

Hi Lisa,
Of course, you may share my contact information. I also accepted the meeting invitation you sent me. I have ...

Feb '21

Hola Maria! Great question, and I volunteer as well! Happy new year!

Feb '21

Hi Tamira!

Sweet! We are scheduling our first planning meeting for next week. Would you be interested in ...

Feb '21

Hola Tamira! Welcome aboard! it will be great having you collaborating with us on this effort. Hope you can attend ...

Latest Resources

Division Leadership Team

Senior Leadership Team
Chair	Lisa Grosskopf
Chair Elect	Teresa Cherry
Treasurer	Anesh Tilwani
Secretary	Scott Moeller
Past Chair	Karen Brozowski
ASQ Segment Manager	Katie Chitwood
...
...

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, 2021 Chair, Scott Blood, 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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Public

Members:

2456

Community Admins