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Medical Device Postmarket Surveillance (PMS) Program Implementation Training

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.