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

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
The new 4th edition of the Certified Medical Device Auditor Handbook, H1572, has been published. I got my copy today.
Part I on Auditing contains new content on Data Privacy, Data Integrity Principles, and the Medical Device Single Audit Program (MDSAP). Part II on Medical Device Quality Management System Requirements contains an entirely new Chapter 6, as the subject of “The EU Medical Device Regulation” has replaced “The EU Medical Device Directives.” Chapters ... more
Posted by David Manalan on Medical Device Division (Formerly Biomedical Division) Feb 20, 2021 1:46 PM CST
FYI -IVDR/MDR 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
Posted by Lisa Grosskopf on Medical Device Division (Formerly Biomedical Division) Jan 12, 2021 7:01 PM CST

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Recent Discussions

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Christine Caruso
60601-1 General Standard plus particular standards
2
- the company I work for creates an x-ray component integrated into a larger medical device. 60601-2-44 applies to ...
Christine Caruso 1d
Norm Howe
Looking for help with a De Novo medical device ...
4
We're looking for someone with De Novo submission experience. If you're interested please contact me.
Norm Howe Mar '21
Lisa Grosskopf
Updated Division Name: Medical Device Division
13
In the summer, the ASQ Biomedical Division was re-named to the ASQ Medical Device Division. This change is ...
Lisa Grosskopf Jan '21
Maria Arciga-Morales
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
Lisa Grosskopf Lisa Grosskopf Jan '21
Hi Maria!

What a great question!  The Medical Device Division has many members that have worked with combination ...
Maria Arciga-Morales Maria Arciga-Morales Jan '21
Hi Lisa!

Thank you for replying to my post. Based on the description of the Healthcare Quality and Improvement ...
Lisa Grosskopf Lisa Grosskopf Jan '21
Hello again!

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

I will reach out to ...
Lisa Grosskopf Lisa Grosskopf 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 ...
Maria Arciga-Morales Maria Arciga-Morales Feb '21
Hi Lisa,
Sorry for replying until now. I could not find the chain of this conversation. I am still interested on this ...
Lisa Grosskopf Lisa Grosskopf 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 ...
Maria Arciga-Morales Maria Arciga-Morales Feb '21
Hi Lisa,
Of course, you may share my contact information. I also accepted the meeting invitation you sent me. I have ...
Tamira Sapp Tamira Sapp Feb '21
Hola Maria! Great question, and I volunteer as well! Happy new year!
Lisa Grosskopf Lisa Grosskopf Feb '21
Hi Tamira!

Sweet! We are scheduling our first planning meeting for next week. Would you be interested in ...
Maria Arciga-Morales Maria Arciga-Morales Feb '21
Hola Tamira! Welcome aboard! it will be great having you collaborating with us on this effort. Hope you can attend ...
Lisa Grosskopf
ASQ Medical Device LinkedIn Group
12
Link to LinkedIn Group: Check out the new ASQ Medical Device Community Page! ...
Lisa Grosskopf Jan '21
Ali Negahi Shirazi
New Member of ASQ Medical Device Division
10
Hello everyone,  I am Ali Negahi Shirazi, a Biomaterials Scientist and a CSSGB, and MBA candidate. Being new to ...
Ali Negahi Shirazi Nov '20
Dan O'Leary
Degradation Analysis
5
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
Medical Device Telemetry Usage
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
John Thomas
Certified Validation Engineer?
3 27
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 ...
Lisa Grosskopf 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 Ajit Basrur Jan '21
Absolutely - the "Validation" could be an overarching concept to include Equipment, Process, Software, ...
Omri Arielly
Clean Room validation
1 19
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 ...

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    Category:
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    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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