3 min reading time

From the looks of things, pretty big. If you tuned into the first of FDA’s Case for Quality webinars, you learned about FDA’s shift their from ‘compliance with regulations’ to ‘device quality.’

Get the replay and register for part two at https://medgroup.biz/FDAq2

Part 1 covered areas of focus that yield higher productivity, fewer complaints, fewer CAPAs and investigations, and lower quality-related product costs.

Specifically:
• What CfQ is and how FDA is engaging;
• Summary detail on CDRH pilot programs;
• How FDA is rethinking regulations.

For Part 2, learn about the:
• ‘Critical To Quality’ pilot program
• ‘Manufacturing and Product Quality’ pilot program
• Issues and concerns FDA is hearing from constituents

Guys, it doesn’t get much better than this. Cisco Vicenty works at FDA right now as the FDA Case for Quality program manager. And you can ask direct questions during the live event, August 16 at 11:45 New York time.

Come if you do QA, RA, Clinical Affairs, R&D, or any kind of medical device engineering.

Props again to Greenlight Guru’s @Jon Speer for arranging.

Your free registration and Part 1 replay at https://medgroup.biz/FDAq2.

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YOU’LL BE SO PROUD OF ME
I made a helluva lot of progress on a major site overhaul for MedicalDevicesGroup.net this week – I may have it ready by this time next week.

All this in light of the impending destruction of our Group.
See https://medgroup.biz/fate for details.

Please, visit 🔥 https://medgroup.biz/stay 🔥 if you want to stay active in the group. I’m serious.

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PLEASE COME to 10x for ENGINEERS
Our in-person meetings take a heightened importance now. See https://medgroup.biz/10x and seriously consider attending. Early pricing ends July 31 so register now for savings.

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Thanks for sticking with me during this transition off LinkedIn,

Joe Hage
Medical Devices Group Leader

P.S. Visit 🔥 https://medgroup.biz/stay 🔥 to stay active in the Medical Devices Group.

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Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
Bald. But not crazy. 🤪

Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
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).

Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
Ian Hendra, I love your analogy! Got a real kick out of it.

Julie Omohundro
Principal Consultant at Class Three, LLC
Mark, to do what? Get the mule to water?

Julie Omohundro
Principal Consultant at Class Three, LLC
Jon, what did you suspect? And what is it about the CfQ that is patient-centric?

Julie Omohundro
Principal Consultant at Class Three, LLC
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.

Jon Speer
Founder of Greenlight Guru – Helping medical devices get to market faster with less risk
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?

Peggy James
Pediatric Nurse at PHH
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.

Mark Rutkiewicz
VP Quality at Innovize, Founder of Consiliso LLC, Medical Device Executive Consultant
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

Tom Flessor
Proven Senior Operations Executive I Helping Companies Transform Business Plans to Excellent Results
The industry should be proactive on this effort and propose product quality guidelines to the FDA.

Ian Hendra
Chartered Quality Professional, Director at Clearline
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.