Join Catherine Tyner, Head of Clinical Strategy, AG Mednet; and Craig McLendon, former Vice President, Adjudication, ...

As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...

After the target markets have been established for a medical device, it is critical to review the relevant national deviations to IEC 60601-1. Understanding these deviations enables manufacturers to ...

To some extent, many organizations, if not all, suffer from some form of performance deviation. This can manifest itself in any goal or standard against which organizations may measure themselves.

The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for ...