Specifically for the USA, we can act as a US Designated Agent for foreign companies with no local representation. We can also assist in registration and listing of devices with FDA.
Person Responsible for Regulatory Compliance” (PRRC)
We can serve as the “Person Responsible for Regulatory Compliance” (PRRC) for “micro and small enterprises” per the new European MDR requirements.
We can also provide customized training on-site in a variety of areas such as Quality Assurance, regulatory matters, clinical matters, etc.