An employer guide to mapping evidence, quality, regulatory, software, and usability responsibilities before defining permanent hiring needs for IVD validation during an applicable Section 564 emergency.
Emergency IVD Validation: How Medical-Device Employers Can Define the Team Read More »
Define medical-device human-factors responsibilities around users, environments, use-related risk, evaluations, and documentation before opening a permanent search.
Medical Device Human Factors Roles: Define the Work Before You Hire Read More »
A practical handoff map for medical-device teams working on autonomous or remotely teleoperated systems, based on topics FDA has opened for discussion.
Four Team Handoffs to Define for Autonomous and Remotely Operated Medical Devices Read More »