PMS service

Operating a Post-Market Surveillance (PMS) system required by the Medical Device Regulation (MDR) is a major challenge for many manufacturers.

Continuous data collection, data analysis, reporting and implementation of corrective actions is a complex and time-consuming process that requires constant attention and expertise.

PMS services:

• Preparation of the PMS Plan

• Preparation of the PMS Report / Periodic Safety Update Report

  • PMS Data Collection

  • PMS Data Analysis

  • Compilation of PMS Report/ Periodic Safety Update Report

PMCF services:

• Preparation of the PMCF Plan

• Conducting PMCF clinical investigation / PMCF studies

  • PMCF Study planning

  • PMCF Study Regulatory authorization

  • PMCF Study Clinical Monitoring

  • Preparation of the Clinical Study Report

• · Preparation of the PMCF Report

  • Data collection through literature review

  • Analysing the data from the literature review

    • Preparing Systematic Reviews

    • Preparing Meta-analysis

• Finalization of the PMCF Report

Technical Documentation Maintenance Services:

• Regular PMS data and literature review

• Updating the Risk Management File based on the PMS Report/PSUR

• Updating the Usability Engineering File based on the PMS Report/PSUR

• Updating the Biological Evaluation Report based on the PMS Report/PSUR

• Updating the Clinical Evaluation Report based on the PMCF Report

Training courses

• MDR PMS/PMCF system requirements

Audit

• MDR PMS/PMCF system audit