Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.
No, the goals for IVD studies are the same as the goals for other device studies, even if the IVD study is exempt from IDE requirements. The FDA recommends that the sponsor and the investigators conduct an IVD device study with the goals of…
Producing valid scientific evidence demonstrating reasonable assurance of the safety and effectiveness of the product, and
Protecting the rights and welfare of study subjects.