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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 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.
For Part 2, learn about the:
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.
YOU’LL BE SO PROUD OF ME
All this in light of the impending destruction of our Group.
Please, visit 🔥 https://medgroup.biz/stay 🔥 if you want to stay active in the group. I’m serious.
PLEASE COME to 10x for ENGINEERS
Thanks for sticking with me during this transition off LinkedIn,
P.S. Visit 🔥 https://medgroup.biz/stay 🔥 to stay active in the Medical Devices 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).
Frankly, the Case for Quality is patient centric (i.e. “quality”), which should be our charter to begin with.
Or am I crazy?
“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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