Every year, the FDA puts out new documents with regulations for medical devices.
Every year, quality teams up their caffeine intake and put in a lot of late nights struggling to understand said regulations.
Take this title, from the FDA 2018 guidance document: “The Application of Acceptable Uncertainty to Support Marketing Authorization Decisions for Medical Devices”
What does that mean? Is that even a thing? Why, yes, yes it is.
But take heart – even a professional with years of regulatory background can struggle to decipher these documents.
You may wonder – Which ones apply to my device? How do I execute these new requirements, and what is the impact on our device?
You may even consider a career change to something less regulated. Like gardening. Or tending bar. Maybe becoming a Starbucks barista.
Don’t throw in the towel just yet. I have the experience to make sense of the insensible, translating the complexities of FDA documentation into a regulatory plan that will work for you.
So put some time on my calendar, and let my Southern charm take the sting out of FDA documentation.