Advanced Certificate in Medical Device Vigilance

Learn the information required to report medical device adverse events (MDAEs), including general report details, reporter type, device category and details, event description, patient information, causality, RCA, and manufacturer actions.

Explore reporting guidelines for medical device adverse events (mdaes) across countries, including usa fda rules, Health Canada, eu, Australia, Japan, and India, with timelines, mechanisms, and penalties.

Develop postmarket surveillance of medical devices by monitoring quality, safety, and performance after market release, and reduce preventable adverse events to protect patient safety through regulatory harmonization.

Explore baseline studies for medical devices through questionnaires that capture adverse events, recalls, field safety notices, and health facility demographics, plus device information, incident details, and causality considerations.

Describe the India medical device adverse event reporting form used in the vigilance program, covering reporter eligibility, device and event details, causality, and submission options.

Learn to assess causality between medical devices and adverse events using qualitative and quantitative methods, establish strength of association, and apply standardized classifications like not related, unlikely, possible, probable, unassessable.

Examine regulatory actions and recall strategies for medical devices, including licensing, proactive inspections, and responsive investigations, plus effectiveness checks and health hazard types to guide post-market vigilance.

Explain the field safety corrective action (FSCA) form, its types and required device and regulatory details for notifying CDSCO about recalls or corrective actions.