PMS Processes Training within the Scope of (EU) 2017/745 Medical Device Regulation (MDR)

To actively and systematically collect, record and analyze relevant data on the quality, performance and safety of the medical device throughout its life cycle after it is placed on the market, and to determine, implement and monitor corrective and preventive actions; It has gained even more importance with the implementation of the (EU) 2017/745 Medical Device Regulation. Relevant activities are carried out together with authorized representatives, importers and distributors and have become an important part of the manufacturer's quality control system. Performing effective monitoring contributes to achieving the outputs of a PMS Plan that can reduce the risk of adverse events.

Purpose of Training:

The training is designed to provide you with an understanding of the PMS and Vigilance process, including the legal requirements for PMS and Vigilance processes and details of how they are carried out. Practical activities and exchange of ideas within the scope of the training contribute to the effective execution of PMS and Vigilance processes in your company after the completion of the training.

Content of the Training:

What does a post-market surveillance system (PMS) include?

PMS requirements in MDR

Impact of PMS process on Technical Documentation

Preparation of PMS plan

PMS Report

Periodic safety update report (PSUR)

Post-market clinical follow-up (PMCF) plan

PMCF report

After-sales surveillance responsibilities of companies certified by 93/42/EEC

How to Operate the Vigilance Process in MDR,

Differences between MDD and MDR in the vigilance process

Trend Reporting

Reporting Adverse Events

Situations That Do Not Require Reporting

Practical Activities on Vigilance Examples

MIR Form, FSCA, FSN, NCAR

Vigilance Guidance Documents for Specific Devices

Who Should Participate:

• Licensing Experts
• Medical Device R&D Engineers
• Medical Device Manufacturers
• Internal and External Auditors
• Quality Managers
• Development, Production and Marketing Managers
• Clinical Experts
• People who want to improve themselves in PMS processes
• Consultants
• Vigilance, PMS officers

Benefits of Education:

Ability to define PMS and Vigilance process changes within the scope of MDR

Ability to determine the basic requirements in PMS and Vigilance processes according to MDR, MEDDEV 2.12-1 Rev8, Meddev 2.12.2 rev.2 and relevant MDCG guides.

Ability to outline the stages and documentation requirements of the PMS and Vigilance process

Ability to determine when vigilance reporting and trend reporting is required for a medical device

Reference Sources:

(EU) 2017/745 Medical Device Regulation

MDCG Guides

Tuition Fee:

Please send an e-mail to info@udem.com.tr to get information about training fees. If there are 3 or more participants from the same company/institution, a 10% discount will be given. A 10% discount will be provided for participants who register early.

Education Record:

To complete the training registration, please fill out the training registration form in the link below and send an e-mail to info@udem.com.tr.

Detailed Information:

For detailed information about the training, you can contact us through the following communication channels.

Tel: +90 312 4430390

Mail: info@udem.com.tr