Emilie Mayeur

Managed the Post-Market Surveillance (PMS) department and supervised products on the market.

Responsible for conducting post-market surveillance activities, including preparing regulatory reports such as PSURs (Periodic Safety Update Reports) and PMPFRs (Post-Market Performance Follow-up Reports), as well as conducting trend analyses.

These analyses were based on the aggregation of data from complaints, non-conformities, CAPAs, patient returns, clinical activities, customer surveys, and other relevant sources, in accordance with IVDR 2017/746 and applicable international standards.

I also successfully led several external company audits, all concluded without any non-conformities or observations.

Assignment at DIAGAST (via Amarylys)

Structured and implemented the Post-Market Surveillance (PMS) process for in vitro diagnostic medical devices (IVDs).

Drafted PMS procedures and trend analyses, as well as PMS Plans, PMPF Plans, PSURs, PMPFRs, and trend reports for Class A, B, C, and D devices, in compliance with IVDR 2017/746.

I also successfully led the GMED audit, which highlighted the robustness of the PMS process and the quality of the trend analyses.

The auditor emphasized the clarity, consistency, and effectiveness of the implementation.

Managed the Post-Market Surveillance (PMS) process: drafting PSURs, PMS plans, monitoring PMS and vigilance indicators, and performing trend analyses on field incidents.

Registered and analyzed complaints related to CE-marked medical devices.

Documented and analyzed adverse events occurring during clinical trials.

Managed product recalls and Field Safety Corrective Actions (FSCA).

The devices concerned were Class IIa medical devices, in full compliance with MDR 2017/745 and FDA requirements.

Successfully conducted external audits, all concluded without any non-conformities or observations.