We hear this question quite frequently from small medical device companies.
Usually what they’re really asking is: “How do I get the FDA to let me sell my device without using Design Controls?”
Short answer: You don’t.
In order to get your product to market, achieving and maintaining compliance is absolutely necessary and ideally it starts from the very first product draft.
However, we recognize that many companies:
Fully understand their product and it’s intended use and have spent a ton of time and money developing it but might not have performed all of the testing required by the FDA
Know in detail how it was designed, but perhaps don’t have a formal Design and Development Process
Are well aware of the risks of the device, but very often don’t have a formal Risk Management Program
Now, you need to get clearance for a 510K Premarket Notification, and you’re overwhelmed by the FDA’s “help” documents.
Don’t go it alone.
Trying to get FDA Approval on your own can lead to costly delays, massive frustration, and significant setbacks in getting your product to market and generating revenue.
In fact, fully understanding regulatory and quality compliance requires a level of insight and knowledge few organizations possess.
The team at Delta Consulting Alliance has the knowledge, experience, and expertise necessary to complete the process of FDA 510(k) submission completely, accurately, and swiftly for your device.
What separates Delta Consulting Alliance from others?
We utilize our consultants to focus on what they love to do, not just what they are able to do, or even like to do
The consultant selected for your 510(k) will have experience with the specific FDA product code applicable to your product
If we do not have a consultant with experience your product requiring a 510(k), we will say so immediately, so you can find a consulting firm that is a better fit
If you haven’t documented the Design Controls, we can help you through our Design Controls and Risk Management Service
We invite you to schedule a custom consultation to discuss your specific FDA compliance issues.
We can help you determine what to do, how much it will cost, and how long it will take to make that 501(k) go away.
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