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A client of mine recently received a FDA Form 483 with multiple inspection observations and they wanted to know how to prioritize their corrective actions. Typically companies will work on corrective actions for each 483 observation in parallel. Howe...
Long-time readers won't be surprised that my dear friend, regulatory expert Robert Packard is offering to teach an FDA pre-submission workshop for free. In fact, the last time we held this workshop – some 3½ years ago – more than 1,500 members regist...
*This is not professional advice.* In fact, it's borderline irresponsible, but here goes. So I was talking to this guy who found me from the group. To protect his anonymity, I'll be vague about his selling proposition. He told me he's building an app...
Head of Quality and Regulatory Affairs
Hi all, I was wondering if anyone had much experience with the safety and performance guidance that came in at the start of Feb? I was trying to find the list of eligible device types but have had no luck as yet.
COO at Mount Mfg
How common are random FDA audits for device manufacturers? Does the FDA focus mainly on class 3 device companies? Do they ever randomly audit contract manufacturers? Can anyone share any insight into this topic for me? As always I appreciate your com...
To ring in the new year, https://medgroup.biz/pre510k. This is a three-hour replay and the 108 slides from David Amor and Jon Speer's presentation at last year's 10x Medical Device Conference. We're making them available this week for $59 (guests pai...
In his insightful 10x Conference talk at http://medgroup.biz/Gulfo, Dr. Joseph Gulfo explained the official FDA mandate: To promote the public health by PROMPTLY and EFFICIENTLY reviewing clinical research and taking appropriate action on the marketi...
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://medg...
Does anybody have good advise or good articles about getting medical devices approved by FDA or similar in other countries?
As originally asked by
Ooh, I've got a good one for you today: An FDA regulator is giving a special 90-minute webinar for Greenlight Guru and the Medical Devices Group. Shout out to Jon Speer for arranging. Your free registration at https://medgroup.biz/case-quality. Franc...