Navigating Worldwide Post-market Surveillance (PMS)

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This rigorous course/webinar offers comprehensive instruction on the PMS requirements for major worldwide regions and regulatory systems, such as the United States of America Canada, and the European Union, among others. Participants will gain the practical skills and critical knowledge needed to successfully establish, document, implement, and maintain post-market surveillance, ensuring compliance and quality after device launch.

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This training takes place in one of two formats (your choice): 

• Two-day in-person training (8 hours/day) located at your site

• Four-day remote online training (4 hours/day)

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Worldwide PMS for Medical Devices Course Objectives:

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After taking this course, you will be able to:

• Define and establish a PMS process to collect, appraise, analyze, and report PMS data

• Author a PMS Plan based on ISO/TR 20416:2020

• Understand the connection between the PMS system and other Quality Management System (QMS) sub-systems, such as Risk Management and Clinical Evaluation

• Differentiate certain requirements for common countries/regions

 

Who should take this course?

• Quality Engineers, Medical Safety, and complaint handling team members new to their jobs

• Team members that require proof of training in PMS (certificate awarded at end of course)

• Experienced device professionals looking to brush up on regulations

• Recommended for professionals in QA/RA, Marketing, Production Management, and any role associated with post-market device lifecycle management

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Course Overview

 

Quality Management System Requirements

• The PMS sub-system of the Quality Management System (QMS)

• The PMS sub-system as a process

• Regulatory requirements for PMS

 

Building a PMS System

• Components of a PMS system

• Necessary PMS procedures

• Assessing an existing PMS system

 

The PMS Plan

• Structure of a PMS Plan

• Requirements for reviewing/updating the PMS Plan

• Interaction of PMS Plan with other QMS sub-systems

 

PMS Data Requirements

• Using the five stages of Clinical Evaluation for PMS

• Identification and collection of PMS Data

• Appraisal of PMS Data

• PMS Data analysis

 

PMS Reporting 

• The PMS Report according to ISO/TR 20416:2020

• The PMS Report vs. the Periodic Safety Update Report (PSUR)

• Relationship between PMS & Post-market Clinical Follow-up (PMCF)

• The Summary of Safety & Clinical Performance (SSCP) for the EU

 

PMS Documentation and Linkages

• EU Technical Documentation relationships to PMS

• PMS role in Management Review

• MDSAP requirements for PMS

• Linkages to the Clinical Evaluation Report and Risk process

 

Audit Preparation

• The process approach to audits

• Auditing of Technical Documentation by a Notified Body

• Other types of national / ISO audits

• Developing a successful audit strategy​​