How big a deal is FDA’s Case for Quality?

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From the looks of things, pretty big. If you tuned into the first of FDA’s Case for Quality webinars, you...

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Posted by Joe Hage (Discussions: 1, Comments: 2)
Replied on July 24, 2018 12:00 am
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The industry should be proactive on this effort and propose product quality guidelines to the FDA.
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Posted by Tom Flessor (Discussions: 0, Comments: 1)
Replied on July 23, 2018 8:00 pm
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I think we need to be very careful here. We need to separate what is Caesar's from what is God's.

"Regulatory conformity" is only one of the parameters that fall within the scope of a full quality management system. The FDA's regulations and those from the other MDSAP brigade are silent on the supply of devices that satisfy "customer requirements" beyond regulatory conformity. For example, "delivery-in-full", "on-time", "in-specification" and "on-budget" do not feature in any medical device regulation (MDR) even though they have always been the core objectives for every customer-centric quality system worthy of the name.

ISO 9001 is the applicable standard here, but it's in the voluntary sector.

Hence, if the FDA wants to play in the voluntary sector of full-blown quality management systems, they need to separate themselves from their regulatory role and understand there is much more to customer satisfaction than just meeting MDRs.
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Posted by Ian Hendra (Discussions: 0, Comments: 4)
Replied on July 23, 2018 8:00 pm
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Ian Hendra, I love your analogy! Got a real kick out of it.
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Posted by Joe Hage (Discussions: 1, Comments: 2)
Replied on July 23, 2018 8:00 pm
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Ian, well said, agreed, and then some. Even a full-blown QMS is just a system for managing quality; it is not a system for producing it.
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Posted by Julie O. (Discussions: 8, Comments: 316)
Replied on July 24, 2018 8:00 pm
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I have to admit, when I heard about the FDA Case for Quality, I raised an eyebrow of suspicion. Upon further investigation and discovery, the Case for Quality is a very progressive, refreshing program that we in the medical device industry should embrace and adopt.

Frankly, the Case for Quality is patient centric (i.e. "quality"), which should be our charter to begin with.

Or am I crazy?
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Posted by Jon Speer (Discussions: 0, Comments: 6)
Replied on July 25, 2018 8:00 pm
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Bald. But not crazy. 🤪
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Posted by Joe Hage (Discussions: 1, Comments: 2)
Replied on July 25, 2018 8:00 pm
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Jon, what did you suspect? And what is it about the CfQ that is patient-centric?
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Posted by Julie O. (Discussions: 8, Comments: 316)
Replied on July 26, 2018 8:00 pm
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I have been involved from the very beginning and it is a refreshing change for the FDA to use a carrot instead of a stick
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Posted by Mark Rutkiewicz (Discussions: 0, Comments: 1)
Replied on July 26, 2018 8:00 pm
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Mark, to do what? Get the mule to water?
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Posted by Julie O. (Discussions: 8, Comments: 316)
Replied on July 26, 2018 8:00 pm
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How much longer will you be on Linkin. I have enjoyed the subjects. I apologize for not commenting very much. I am currently in process of getting my sons murder solved.
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Posted by Peggy James (Discussions: 0, Comments: 2)
Replied on July 29, 2018 8:00 pm
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Peggy, the group will still have a place on LinkedIn, it's just I may not have the tools necessary for it to be a positive customer experience once they remove my ability to write you AND my ability to keep spam out of the group.

That's why I rushed a production of a revised https://MedicalDevicesGroup.net through last week. I encourage you to make sure you're in that database so I can continue to share updates like these with you.

See https://medgroup.biz/stay to do so (although I believe you, personally, are already there; you might check).
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Posted by Joe Hage (Discussions: 1, Comments: 2)
Replied on July 30, 2018 8:00 pm
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