We will work with you to build a regulatory strategy for your device. This includes determining what classification your device is, if there are any predicate devices, and figuring out the best type of FDA pre-market submission for your device. We will also identify any risks and lay out a plan before heading to production of your device.
EMMA International proudly partners with New Concept Technology in order to manufacture your device. New Concept Technology’s facilities have a state-of-the-art class 100K clean room that are ISO 1464-1 Class 8 Certified, and they specialize in medical cable over molding, medical process automation, and expert medical assembly. While your device is being prepped for manufacturing, EMMA will continue to assess all aspects of the process for regulatory compliance.
EMMA International will summarize and review the regulatory strategy of your device with you so you understand expectations and timelines. We will also prepare the submission and submit to the FDA on your behalf. If there is any feedback from the FDA, we will act as a liaison as well.
EMMA International will continue to support your device even after it is cleared through the FDA. We can build and maintain a robust QMS that can develop as your device and business develops. We will help you stay compliant to both FDA regulations as well as international standards, like ISO 13485. With this we can help you market your device worldwide!!
We’re here to help with all your product development needs. Get in touch below.