Post Market Surveillance
Course Outline Suitable for anyone who has a part to play in Vigilance and Post Market Surveillance (PMS), this course focuses on practical advice and workshops that will improve your organisation’s performance in this area. Topics studied include the terminologies of PMS (proactive) and Vigilance (reactive); European and FDA regulatory requirements; recalls and field safety notices; and when, how and where to report adverse incidents. We also look at Post-Market Clinical Follow-up (PMCF), which is increasingly the focus for manufacturers entering the market with new devices. The course explains the PMCF requirements, how to evaluate the need for PMCF, and the best approach for designing PMCF plans. By the end of the course, you should understand all the regulatory requirements for PMS and Vigilance, and have a better idea of how to integrate PMS and PMCF activities into your EN ISO 14971 risk management cycle. As a result, you should be better placed to meet your regulatory obligations effectively.
and Adverse Event Reporting