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Medical Device Postmarket Surveillance (PMS) Training

Regulatory bodies are increasing their focus on postmarket surveillance (PMS), as evidenced by the more stringent requirements of the EU MDR and IVDR and the establishment of PMS as a core process within the MDSAP program. In this class, you will learn practical steps for collecting, analyzing, reporting, and applying postmarket data, as well as how to connect the PMS process to QMS and risk management processes. Using the ISO/TR 20416:2020 guidance as a foundation, you'll gain the knowledge and skills to establish and maintain a postmarket surveillance system that conforms to ISO 13485:2016 and ISO 14971:2019 and also satisfies the regulatory requirements of EU MDR and IVDR, MDSAP, and other country-specific stipulations.

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Brief Overview of This Postmarket Surveillance Program Implementation Course

SkillsLab Class ?

Class Content

In-Depth

Class Duration

5 Half-Days*

Teaching Format

Live, Instructor-Led

Delivery Options

Virtual or In Person**

Certification of Completion

Yes

Continuing Education Units (CEUs)

2.5

* SkillsLab classes delivered in-person (private or public) are full-day sessions delivered over 3 consecutive days. 

** Interested in private training for your team, virtually or in-person at your facility? See more details or ask us about it!

Upcoming Classes

Upcoming Medical Device Postmarket Surveillance Implementation Classes

SkillsLab $3295

There are no public training classes scheduled right now but this class can be delivered privately to 6 or more people at any time. Ask us for details!

GROUP DISCOUNT

Save up to

25%

Register 3 people, 4th attends free!

Free

*This offer cannot be combined with any other promotional offer(s).

Course Overview

Here's What We Cover in This Intensive Medical Device PMS Training Course

Learn to use the ISO/TR 20416:2020 guidance and regulatory requirements to implement and maintain a sustainable, compliant PMS system that ensures the benefit-risk ratio of your medical device remains acceptable throughout its service life. During the course, you will gain the knowledge and practice the skills required to implement a dynamic, connected system that triggers actions in related QMS and regulatory systems. Use helpful tools, relevant examples, and hands-on workshops to write a PMS plan, and establish a working process to collect, analyze, report, and use relevant postmarket data as evidence that a medical device is – or is not – a safe, effective, and state-of-the-art device. 

Course Overview
SkillsLab Class

Quality Management System Requirements

  • QMS and regulatory requirements related to postmarket surveillance (PMS)
  • Roadmap to conformance and compliance
Workshop! Document a PMS Process

Postmarket Surveillance System

  • Building the PMS system
  • PMS procedure writing
Workshop! Assess for PMS Requirements

Writing the PMS Plan

  • PMS plan purpose, structure, writing, review, and update
  • PMS interfaces to other QMS processes
Workshop! Develop a PMS Plan, Parts 1 and 2
Workshop! Formulate PMS Objectives

Data Collection, Appraisal, Analysis, and Trend Analysis

  • Identify a comprehensive list of relevant data sources
  • Collect and connect data to your program
  • Appraise data to determine validity
  • Select appropriate methods of analysis, and analyze data to understand device safety and effectiveness
Workshop! Who Has the Data?
Workshop! Using Databases; Develop an Approach to Data Analysis

Postmarket Surveillance Reporting and Follow-Up

  • PMS reporting (PMSR), aligned with ISO/TR 20416:2020 guidance and regulatory requirements
  • The relationship of postmarket clinical follow-up (PMCF), periodic safety update report (PSUR), and
    summary of safety and clinical performance (SSCP)
  • Trend reporting
Workshop! Develop a Plan for Postmarket Surveillance Reporting (PMSR)

Technical Documentation and PMS Linkages to QMS Processes

  • Life-cycle management of technical documentation
  • Feedback and postmarket surveillance in management review
  • Requirements of the QMS and MDSAP
  • Linkages between PMS reporting, clinical evaluation, and risk
  • Regulatory databases and PMS
Workshop! Building Postmarket Surveillance into Management Review
Workshop! Organize Postmarket Technical Documentation
Workshop! Identify Linkages

Successful PMS Audit Outcomes

  • Notified Body approach to QMS, technical documentation, and unannounced audits
  • Implementation action planning
Workshop! Develop an Action Plan for a Successful PMS Outcome
What You Will Learn

What You Will Learn

At the conclusion of this training class, you will be able to
SkillsLab

Implement a PMS process aligned with ISO/TR 20416 that meets EU MDR, EU IVDR, and MDSAP requirements.

Define and establish an efficient process to collect, analyze, report, and use postmarket data. 

Create a postmarket surveillance plan based on ISO/TR 20416:2020 guidance and industry best practice. 

Discuss how the PMS system connects to dependent systems, such as the quality management system, risk management
system, and CER system. 

Use relevant country-specific requirements to inform the PMS process, planning, and reporting.  

Who Should Attend

Who Should Attend

Medical device professionals involved in postmarket surveillance, complaint handling, incident reporting, and regulatory compliance. Others who play a role in a manufacturer’s PMS process – such as importers, distributors, and reprocessors connected to manufacturing processes – will also benefit. 

  • Importers
  • Distributors
  • Reprocessors
  • PMS Personnel
  • RA Professionals

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