Janet Pulver

Janet conducts comprehensive inspections with key focus on procedural and documentation compliance. She prioritizes issues that directly affect the safety of the end-users such as uninvestigated device failures, inadequate complaint handling, and unreported health risks.

Investigator Janet Pulver is rigorous, methodical, and highly focused on compliant practices relating to medical devices, prominently focusing on Corrective and Preventive Actions (CAPA), complaint handling procedures, and timely reporting of incidents. She particularly highlights areas of device failure investigation and reporting, risk analysis, design verification, and software validation as seen in her observations. Beyond these technical aspects, she also places importance on timely submission of necessary documentation and reports.