For software that falls under the medical device category, does coding have to follow a specific guideline or standard to be FDA compliant?
As originally asked by
FDA has an agreement with EPA where low-level disinfectants used in areas like hospital rooms are regulated by EPA. A client has a low-level EPA-approved disinfectant cleared to inhibit microbial growth on the surface to which it is applied. But rece...
Executive Business Coach & Sales Leader
I work for a class II medical device manufacturer that has never done anytime of marketing. My job is to get us into the 21st century with aligning us with the way buyers want to educate themselves and buy - which is digital marketing strategies. How...
Ship & Print Your FDA eCopy
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...
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...
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...
Long-time readers won't be surprised that 13485-expert Robert Packard's workshop at the 10x Conference was standing room only. Or that he offered to teach his class for free. Register at http://medgroup.biz/510k-tips for Rob's free workshop on how to...
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...
Bradley Merrill Thompson, RAC
Medical Device, Digital Health and Combination Product Regulatory Attorney
FDA updates Pre-Cert program as it begins to grapple with ‘hard questions’New updates to the FDA's Software Pre-Cert working model shows the program is making significant gains, but FDA attorney Bradley Merrill Thompson tells FierceHealthcare the age...
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...