What You Will Learn
At the end of this workshop, you will be able to:
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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.
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Discuss in detail conformance to country-specific postmarket surveillance regulatory requirements, including the EU MDR and IVDR.
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Identify and build needed linkages between your postmarket surveillance process and QMS and risk management processes.
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Create a postmarket surveillance plan based on related regulatory requirements and the ISO 13485:2016 and
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ISO 14971:2019 standards.
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Use ISO/TR 20416:2020 guidance to establish a process to identify, gather, assess, and analyze postmarket surveillance data.
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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