'Postmarket surveillance' presentation slideshows

Postmarket Surveillance for Medical Devices

Postmarket Surveillance for Medical Devices. Objectives. Differentiate FDA postmarket surveillance from device manufacturer surveillance activities Define Responsibilities as a Medical Device Manufacturer Introduce Risk management as part of PMS Determine Sources of data

473 views • 39 slides

FDA Regulatory Requirements to Market Medical Devices in the United States (U.S.)

FDA Regulatory Requirements to Market Medical Devices in the United States (U.S.). Carole C. Carey Director CDRH International Staff U.S. FDA Center for Devices and Radiological Health. Outline. Who are we? What we do? (structure and background

575 views • 36 slides

FDLI Introduction to Medical Device Law and Regulation

525 views • 30 slides

Incident Reports and field Safety Corrective Action ( FSCA)

Incident Reports and field Safety Corrective Action ( FSCA). Eng. Essam M. Al-Mohandis Executive Director of Surveillance and Biometrics. Medical Devices Life Cycle. Conception and Design. Manufacture. Packaging Labelling. Advertising. Sale. Use. Disposal. Pre-market.

429 views • 22 slides

Medical Devices Approval Process

Medical Devices Approval Process. Objectives. Define a medical device Be familiar with the classification system for medical devices Understand the difference between medical device approval and medication approval Define 510(k) Premarket Notification

627 views • 15 slides

CDRH: Minimizing Risk of TSE Agents in Medical Devices

272 views • 12 slides