U Care Unlimited LLC

FDA

U Care Unlimited LLC is a Dallas-based regulatory consultancy serving medical device and pharmaceutical companies. Its medical device services include FDA 510(k) and PMA submission consulting, gap assessments, regulatory intelligence and regulatory-affairs training. The firm presents these services as tailored support for companies seeking to strengthen compliance and plan their route through the US regulatory process.

Learn more

Are there FDA requirements for non-device clinical decision support software?

Anonymous · 1 comment

5 months ago

According to the new FDA guidance on clinical decision support software, our software is classified as a non-device. What are the requirements for bringing such software to the US market? Are there st

Accepted 1 answer

If your assessment shows that your product is truly a “non-device” according to the FDA guidance, there aren’t specific FDA requirements you need to m

11:50

FDA and EU - Complaint E-Signatures: Documents and Review Workflow in eQMS Software Formwork

Dr. Oliver Eidel

449 views · about 4 years ago

FDA Compliance

The Ultimate Comparison: ISO 13485 vs. FDA 21 CFR

Updated about 1 year ago

Sebastian Skorka