Community Discussion Category Topics

ASQ Medical Device LinkedIn Group

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

Lisa Grosskopf 6d

Certified Validation Engineer?

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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 Sep '20

JT - I agree with you regarding having a Validation certification. I think it would be great to have one, and ...

Lisa Grosskopf Nov '20

I like this! A validation certificate would be beneficial. A couple of us on the Leadership Team have discussed ...

New Member of ASQ Medical Device Division

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Hello everyone, I am Ali Negahi Shirazi, a Biomaterials Scientist and a CSSGB, and MBA candidate. Being new to ...

Ali Negahi Shirazi Nov '20

Degradation Analysis

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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

Medical Device Telemetry Usage

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

Carolyn Wright Sep '20

Clean Room validation

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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 Apr '20

Start with ISO 14644

At a high level, Environmental Qualification for clean rooms in a GMP facility consist of the ...

Reference Information fact sheet: ANSI / ISO - Common ...

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See attached common acronyms for common ANSI / ISO references.

George Marcel Oct '19

Keith Councell Dec '19

I love that fact that the document creates its own acronym (CUA) instead of just being called "Commonly Used ...

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

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

George Marcel May '19

James Shore May '19

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

Lisa Grosskopf Jun '19

Hi Jim,

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

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 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 Nov '19

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

Proactive Supplier Controls

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

James Shore Nov '19

Call for Biomedical Division Participation - myASQ ...

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Hello Biomedical Division members, As of today 10/21/19, this group on myASQ has grown to 410 so far since launch ...