By definition, all in vitro diagnostics (IVDs) for human use are medical devices. That much is easy to understand: however, classifying medical devices under the IVD umbrella can become complicated when the difference between each category is often unclear. There are...
We invite you to join us at the second session of Indiana Medical Device Manufacturers Council (IMDMC)’s annual Regulatory 101 course on August 19, 2014. This is a popular event designed for staff who are new to the FDA regulatory world or those who just need a...
Pearl Pathways is pleased to announce the hiring of Heidi Hancock Strunk, RAC as a Regulatory Compliance Advisor. Strunk brings over twenty-three years of experience in FDA-regulated industries and thirteen years in management, including extensive expertise in the...
Single IRB – A Guide to the Common Rule sIRB Mandate
The sIRB requirement is active. Is your study affected?
