regulatory affairs

Your first human subjects study changes your risk profile, and your insurance has to keep pace. This guide explains how clinical trial liability coverage differs from general and product liability, what reviewers and sites look for in insurance and consent documentation, how investigator coverage interacts with sponsor liability, and five questions to answer before enrollment begins.

Nearly all medical device recalls are technically voluntary — but that label is doing more work than it should. This guide breaks down the real difference between voluntary and mandatory recalls, why standard product liability policies almost never cover recall expenses, the true operational cost of pulling a device from the field, and how to build recall preparedness into your risk framework before the FDA calls.