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Medical Device Postmarket Surveillance (PMS) Program Implementation Training

Understand how to implement a PMS process aligned with ISO/TR 20416:2020 that meets EU MDR, EU IVDR, and MDSAP requirements.

Regulatory bodies are increasing their focus on postmarket surveillance (PMS), as evidenced by the expanded and 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 and practice 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, participants gain the knowledge and skills for establishing and maintaining a medical device postmarket surveillance system that not only provides inputs to systems that conform to ISO 13485:2016 and ISO 14971:2019 but also satisfies the regulatory requirements of EU MDR and IVDR, MDSAP, and other country-specific stipulations.

Upcoming Dates and Locations

Virtual seminars run as 1/2-day sessions. In-person classes run as full-day sessions. See the virtual session daily class times.

Location Start Date Days Cost Public Course Private
VIRTUAL DELIVERY (Eastern Time) 11/30/2021 4 $1995.00 Add to Cart CONTACT US
VIRTUAL DELIVERY (Eastern Time) 01/11/2022 4 $1995.00 Add to Cart CONTACT US
VIRTUAL DELIVERY (Eastern Time) 02/08/2022 4 $1995.00 Add to Cart CONTACT US

What You Will Learn

At the end of this workshop, you will be able to:

  • Clearly define postmarket surveillance in your organization, and explain the purpose of the postmarket surveillance process within the context of your quality and risk management systems.
  • Discuss in detail conformance to country-specific postmarket surveillance regulatory requirements, including the EU MDR and IVDR.
  • Identify and build needed linkages between your postmarket surveillance process and QMS and risk management processes.
  • Create a postmarket surveillance plan based on related regulatory requirements and the ISO 13485:2016 and
  • ISO 14971:2019 standards.
  • Use ISO/TR 20416:2020 guidance to establish a process to identify, gather, assess, and analyze postmarket surveillance data.
  • Prepare a framework for postmarket surveillance reporting.

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.

Prerequisites

Participants should have experience with or basic knowledge of quality management systems for the medical device industry.

Virtual session participants may also be required to complete a short eLearning module covering basic topics related to the new EU medical device requirements. The eLearning module would be provided to course participants as part of the virtual training classroom, which is sent the week prior to the start of class.

Virtual Half-Days: 4
In-Person Full-Days: 2
CEUs: 1.6

Virtual Session Details

Oriel STAT A MATRIX Virtual Instructor-Led Training (VILT) is a real-time internet-based learning experience where the instructor and learners are in separate locations. Oriel STAT A MATRIX’s VILT technology platform is designed to simulate a traditional in-person classroom experience and allows for 2-way dialogue, break-out sessions for engaged workshops and hands-on exercises, and group work using virtual breakout rooms. This provides for an engaging learning experience in which participants can connect with the content and interact with both the instructor and other classmates.

Online Training Schedule

Convenient half-day format allows you to balance your other responsibilities while still getting the training you need. 

  • This training is delivered as four consecutive half-day sessions, daily from 1:00-5:00 p.m. Eastern time. 

Technical /Logistical Requirements

To participate in this learning, first and foremost, we need your engagement!  You will also need:

VIRTUAL CLASS TIMES Close

Public virtual seminars run daily from 1:00-5:00 p.m. ET. Seminars run on Eastern Time unless otherwise noted in the Location field.

Auditor classes that require a final exam start at 11:30 a.m. on the last day to administer the final exam.

For more information download the virtual course agenda (close this window and navigate to the top of the course page) or Contact Us.

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