Community Home

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 2023
Geographical Discussion Groups
Scholarships and Grants - Academic scholarship deadline extended to May 31!

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

2023 ASQ Minnesota And ASQ Medical Device Division In Conjunction With The Informa MD&M Conference

Minneapolis, Minnesota Call for Sponsors - October 10-11, 2023 The ASQ Minnesota Section and ASQ Medical Device Division are seeking sponsors for our in person conference to be held in conjunction with the Informa MD&M Meeting in Minneapolis. This year’s conference theme is: Old Problems, New Solutions! This is a fantastic opportunity to ... more

Posted by Donna Campbell on Medical Device Division (Formerly Biomedical Division) Apr 27, 2023 7:38 AM CDT

MDD awarded Silver PEP level 2022

Congratulations to the 2022 Awardees for Member Unit Performance Excellence! Published The Performance Excellence Program (PEP) Committee is happy to announce the 2022 recipients of Gold, Silver, and Bronze recognition! Measures included in the 2022 award program were: Contributions to ASQ thought leadership, as measured by myASQ content ... more

Posted by Lisa Grosskopf on Medical Device Division (Formerly Biomedical Division) Apr 21, 2023 8:20 PM CDT

Comments (0)

ASQ Certified Medical Device Auditor Refresher Course

https://www.eventbrite.com/e/asq-certified-medical-device-auditor-cmda-refresher-course-tickets-331556714057 more

Posted by Lisa Grosskopf on Medical Device Division (Formerly Biomedical Division) Apr 19, 2023 10:31 PM CDT

Comments (0)

Upcoming Events

No Data Available

Recent Discussions

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

Medical Device Sampling Plan justification

4 32

Hi Everyone, What are the requirements for Medical Device Sampling Plan justification? I am looking for a ...

Alireza Khosh Jun '22

Jun '22

Sampling plans must be statistically valid. The best way to do this is thru standards such as those available thru ...

Jun '22

I attach two articles addressing this topic. Even though it's old, Torbeck's article should be read before ...

Jun '22

Hi Alireza,

While there is no definitive guidance on sampling plans from the FDA, have used the following for ...

Jun '22

For Medical Devices FMEA Risk is not the same as ISO 14971 Risk. You should use Risk Analysis Risk and not FMEA Risk. ...

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

Poka Yoke Awareness

NSF International is presenting a free webinar “Poka Yoke Awareness” on March 30, 9am EDT. How can you improve ...

Norm Howe Mar '22

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

5 76

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 ...

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

CNC Validation approach

Hello, All my experience in equipment validation is in custom assembly automation dedicated to a single ...

Jesse Benson Mar '23

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

FD&C Poster Share in Boston - Feburary 2023

1 4

The Food, Drug, and Cosmetic Division will be hosting a poster share on February 28th from 3-5 pm in Boston, with a ...

Jeremiah Genest Jan '23

Jan '23

@Jeremiah Genest
Thank you for sharing with the Medical Device Division! Best wishes with this event!

Combination Products

13 59

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

RICHARD J. SCHLESINGER GRANT The Vision of the Medical Device Division of ASQ is to make quality control and assurance in biomedical products and systems as a global priority, an organizational imperative, and a personal ethic. The ASQ Medical Device Division ...
Date Created: 04/19/2023 04:13 AM

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 ...
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

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:

3534

Community Admins